Clinical TRIALS Experience:Happy image 2

 

Phase I Studies:

Principal Investigator of A Double-Masked, Placebo-Controlled, Dose-Escalation Study and Double-Masked, Two-Sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of XXX in Patients with Ocular Hypertension or Mild Open-Angle Glaucoma. 2012.

 

Principal Investigator of A Single-blind, Pilot Study to Determine the Tolerability and Safety of XXXX in Subjects with Opioid-Induced Constipation.  2012.

 

Principal Investigator of  a Phase I Dose-Ranging, Randomized, Double-Blind, Controlled Study of Time to Inject, Safety, and Tolerability of a Subcutaneous Injection of a Viscous Antibody Solution With Human Recombinant Hyaluronidase in Healthy Adult Subjects. 2007.

 

Principal Investigator of a Phase I Pharmacodynamic Bioequivalence Study Comparing Urinary Phosphate Excretion and Plasma Pharmacokinetics of XXXX with Dissolution Characteristics Administered to Healthy Adult Subjects. 2006.

 

Principal Investigator of a Pharmacokinetics and Safety Study of Single Oral Dose of XXXX 40mg, in Mild, Moderate and Severe Renally Impaired Male and Female Patients and Matched Subjects with Normal Renal Function. 2006.

 

Principal Investigator of a Study on Influence of Race/Ethnic Origin on the Pharmacokinetics of XXXX. 2006

 

Principal Investigator of a Phase I, Randomized, Open Label, Single Dose, 3-way

Crossover Pharmacokinetic Study Comparing Plasma Exposure of an HMG-COA Reductase Inhibitor, Another HMG-COA Reductase Inhibitor, and a Hypolipidemic drug in Healthy Chinese, Japanese, and Caucasian volunteers. 2006

 

Principal Investigator of A Single-Dose, Dose Escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous XXXX  in Subjects with Stage 2 to 4 Chronic Kidney Disease. 2006.

 

Sub-Investigator of A Phase 1, Single-Blinded, Randomized Study of Nebulized XXX in Combination with XXX in Adult Subjects with Mild to Moderated Asthma. 2012.

 

Sub-Investigator for A Phase 1 Dose-Ranging Study to Assess the Safety, Pharmacokinetics and Antiviral Efficacy of *** in Healthy Volunteers and Patients with HCV Genotype-1 Infection. 2012.

 

Sub-Investigator for A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability and PK of XXX Following a Single Intravenous Dose in Patients with Rheumatoid Arthritis on Methotrexate. 2012.

 

Sub-Investigator for A Phase 1, Open-Label, Parallel-Design Study to Evaluate the Pharmacokinetics of XXX in Subjects with Severe Renal Impairment. 2012.

 

Sub-Investigator of a Phase I Randomized, Double-blinded, Single-dose, Two-treatment, Two-sequence Crossover Study of in vivo Pharmacodynamic Effects of the Generic Version of an Anticoagulant Injection Versus Another Anticoagulant for Determination of Pharmaceutical Equivalence, 2006.

 

Sub-Investigator of a Rising Multiple Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of High Dose XXXX in Healthy Volunteers. 2006.

 

Sub-Investigator of a Phase I, Open-Label, Parallel Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of XXXX (60 mg) in Subjects with Normal or Moderately Impaired Hepatic Function. 2006

 

Sub-Investigator of a Randomized, Double-Blind, Placebo-Controlled, Single, Intravenous, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerance, and Pharmacokinetics of XXX in Healthy US Japanese Subjects. 2006

 

Sub-Investigator of an Escalating Single-Dose, Observer-Blinded,  Placebo-Controlled Study of XXX-XXX Delivered Intranasally to Healthy Adult Male Volunteers. 2006

 

Sub-Investigator of an Exploratory Study of XXXX to Design Therapeutic Dosing for Chronic Active HCV Patients. 2006.

 

Sub-Investigator of a Randomized, Double-Blind, Placebo-Controlled, Sequential-Group, Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of XXX-XXX Administered Subcutaneously And Intravenously To Subjects With Asthma. 2006

 

Sub-Investigator of a Pharmacokinetics and Safety Study of a Single Oral Dose of XXXXX 350mg, in Mild, Moderate, Severe Renally Impaired Male and Female Patients and Healthy Subjects.

 

Sub-Investigator of A Rising Multiple Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of High Dose XXXX in Healthy Volunteers. 2006

 

Sub-Investigator of A Phase I, Open-Label, Parallel Study to Evaluate the Pharmacokinetics and Safety of a Single Oral Dose of XXXX (60 mg) in Subjects with Normal or Moderately Impaired Hepatic Function. 2006.

 

Sub-Investigator of A Randomized, Double-Blind, Placebo-Controlled, Single,Intravenous, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerance, and Pharmacokinetics of XXX in Healthy US Japanese Subjects. 2006

 

Sub-Investigator of An Escalating Single-Dose, Observer-Blinded, Placebo-Controlled Study of XXX-XXX Delivered Intranasally to Healthy Adult Male Volunteers. 2006

 

Sub-Investigator of An Exploratory Study of XXXXXX to Design Therapeutic Dosing for Chronic Active HCV Patients. 2006.

 

Sub-Investigator of a Randomized, Double-Blind, Placebo-Controlled, Sequential-Group, Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of XXX-XXX Administered Subcutaneously And Intravenously To Subjects With Asthma. 2006.

 

Sub-Investigator of A Phase I Study to Characterize the Dose Linearity in Pharmacokinetics of 5-amino salicylic acid (5-ASA) and Acetyl-5-ASA (AC-5-ASA) for three single doses of XXXXX (1.2g, 2.4g, and 4.8g) and the Pharmacokinetic Profile of XXXXX (4.8g) in the Presence of Food in Healthy Subjects. 2006.

 

Sub-Investigator of a Phase I Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics of an Anti-inflamatory Agent Following Administration of 30mg/kg/day, 60mg/kg/day, and 90mg/kg/day as 400mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children and Adolescents With Active Ulcerative Colitis. 2006

 

Sub-Investigator of a Phase I Double-Blind, Randomized, Placebo-Controlled Study to Assess the Interaction of a Muscarinic Alkaloid and an Anticholinergic in Healthy Male Subjects. 2006.

 

Sub-Investigator of a Study on Pharmacokinetics and Tolerability of an Anti-obesity drug  Cannabinoid Receptor Antagonist (CBA) Given as a 20-mg Single Dose in Male and Female Subjects with Severe Renal Impairment Versus Subjects with Normal Renal Function. 2006.

 

Sub-Investigator of a Randomized, Double-blind, Placebo-controlled Ascending Single-dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of XXX Administered via a Nasal Spray Pump to Healthy Subjects. 2006

 

Sub-Investigator of a Single-Dose, Dose Escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous XXX in Subjects with Stage 2 to 4 Chronic Kidney Disease.  2006.

 

Sub-investigator of a Pharmacokinetics of a new selective estrogen receptor modulator in Subjects with Liver Disease. 2006.

 

Sub-Investigator of a Study to Compare the Pharmacokinetics and Safety/Tolerability of a Single Subcutaneous Administration of a Liquid Formulation of Tumor Necrosis Factor–alpha (TNF-alpha) Inhibitor  to Healthy Male Caucasian and Japanese Subjects. 2006

 

Sub-Investigator of a Study of Pharmacokinetics of Prasugrel Metabolites in Subjects with Moderate Renal Impairment, Subjects with End Stage Renal Disease Requiring Haemodialysis and Healthy Subjects with Normal Renal Function.  2006.

 

Sub-Investigator of a Phase I, Randomized, Observer-blind, Dose-escalating Study in Adult End-stage Renal Failure Patients to Explore the Safety, Tolerability, Pharmacokinetics and Immune Response to XXX Co-Administered with XXX. 2006.

 

Sub-Investigator of a  Phase I, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety and Tolerability of rapidly bactericidal antibiotic Following Administration of Single and Multiple Dose Intravenous Infusions to Healthy, Japanese and Caucasian Males and Female. 2006.

 

Sub-Investigator of an Open-label, Pilot Study to Evaluate Effects of 4-week  Treatment  of a New Oral Hypoglycemic Anti-diabetic Drug on the 2-hour Plasma Glucose Value Following an Oral Glucose Tolerance Test in Subjects with Impaired Glucose Tolerance. 2006.

 

Sub-Investigator of a Study to Evaluate Interaction between XXX and an anti-metabolite drug in Rheumatoid Arthritis Patients Stable on Another Anti-metabolite Drug Dose.

 

Sub-Investigator of a Study to Evaluate the Effect of Food, Age, Dosage Form, and

Antacid on the Pharmacokinetics of XXX When Administered as a 40-mg To-be-marketed Tablet Formulation. 2006

 

Sub-Investigator for a Phase I Randomized, Double-blind, Placebo-controlled Study to Assess the Interaction of two FDA-approved agents in healthy male subjects.  2005.

 

 

Phase 2-4 Studies:

Principal Investigator of A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XXX in Subjects with Asthma. 2012.

 

Principal Investigator of A Randomized, Double-Blind Placebo-Controlled, Parallel Group 6-week Study Designed to Investigate the Effects of XXX on the Hypothalamic-Pituitary-Adrenal (HPA) –Axis in Pediatric Subjects (6 to 11 Years of Age) with Perennial Allergic Rhinitis (PAR). 2012

 

Principal Investigator of A Comparison of the Pharmacokinetic and Pharmacodynamic Profiles of XXX and XXX in Pediatric Patients with Persistent Asthma. 2012.

 

Principal Investigator of Evaluation of Efficacy and Safety for Single Dose of XXX in Children with Asthma. 2012.

 

Principal Investigator of A Long-Term Tolerability and Safety of Immune Globulin (IGSC) Solution administered Subcutaneously Following Administration of XXX in Subjects with Primary Immunodeficiency. 2012

 

Principal Investigator of A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of XXX Administered Twice Daily Compared with Placebo in Adolescent and Adult Subjects with Severe Persistent Asthma Uncontrolled on High Dose Inhaled Corticosteroid Therapy. 2012.

 

Principal Investigator of A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week, Clinical Study Designed to Assess the Efficacy and Safety of XXX once daily in Pediatrics Subjects 4-11 Years of Age with Perennial Allergic Rhinitis. 2012.

 

Principal Investigator of A 12-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of XXX  in Subjects 6-11 Years with Perennial Allergic Rhinitis. 2012.

 

Principal Investigator of An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of XXX as a Treatment for Patients with Eosinophilic Asthma Who Completed a Prior XXX-Sponsored Study in Eosinophilic Asthma. 2012.

 

Principal Investigator of A 12-Week Dose-Ranging Study to Evaluate the Efficacy and Safety of XXX Administered Twice Daily Compared with Placebo in Adult and Adolescent Subjects with Controlled Persistent Asthma. 2012.

 

Principal Investigator of A 12-Week Dose-Ranging Study to Evaluate the Efficacy and Safety of XXX Administered Twice Daily Compared to Placebo in Adolescent and Adult Subjects with Persistent Asthma Uncontrolled on Non-Steroid Therapy. 2012.

 

Principal Investigator of  An Observational Study to Assess Whether XXX Nasal Actuator Tip Fits Adequately into Nostrils of Younger Children (2 to < 6 Years of Age). 2012.

 

Principal Investigator of A Phase IIb Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Dosing Regimens of XXX  In Adults with Allergic Asthma Who Are Inadequately Controlled on Inhaled Corticosteroids And a Second Controller Medication. 2012.

 

Principal Investigator of A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of XXX in the Treatment of Patients with Diarrhea Predominant Irritable Bowel Syndrome. 2012.

 

Principal Investigator of An Open-Label, Multicenter, Pharmacokinetic Study of XXX in Subjects with Varying Degrees of Hepatic Impairment. 2012.

 

Principal Investigator of a Double-blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of XXXX in Subjects with Opioid-Induced Constipation. 2012.

 

Principal Investigator of A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Multi-Center Trial of XXXX to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-Induced Constipation (Compared to XXXX Controlled-release tablets) in Opioid-Experienced Subjects with Controlled Moderate to Severe Low Back Pain and a History of Opioid-induced Constipation. 2012.

 

Principal Investigator of  a Randomized, Double-blind, Placebo-controlled Multicenter Trial with Enriched Study Design to Assess the Efficacy and Safety of XXXX Compared to Placebo in Subjects with Chronic Low Back Pain.  2012

 

Principal Investigator for A Phase II, 28-day, Partially Blinded, Multi-center, Randomized, Parallel-group study to evaluate 200 and 300 ug Daily Nasal Spray Compared to Study medication on Bone Turnover Markers, Pharmacokinetics, and Safety in Postmenopausal  Women.  2006

 

Principal Investigator of a Randomized, Double blind, Placebo controlled, 3 Arm, Parallel group,

Phase II Study Investigating the Efficacy, Tolerability and Pharmacokinetics of Study Medication in

Asthmatic children and Adolescents Over 6 Weeks. 2006.

 

Principal Investigator of a Phase III Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Clinical Trial Designed to Assess the Safety and Efficacy of an inhaled steroid (200 mcg and 100 mcg, once daily)Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis(SAR) in Patients 6 to 11 Years of Age. 2006.

 

Principal Investigator ofa Phase IV 26-week, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multi-center Study to Evaluate the Effect of an Oral Steroid on Improving the Tolerability of Specific Immunotherapy in Patients with Persistent Allergic Asthma. 2006.

 

Principal Investigator of a study of prevalence of Anti -TSST-1 Antibody Titers among Japanese and Caucasian Women in North America. 2006.

 

Principal Investigator of a Phase III Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Leukotiene Receptor Antagonist Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients with Seasonal Aeroallergen Sensitivity. 2006.

 

Principal Investigator of A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of XXX in Subjects with Moderate to Severe Allergic Asthma. 2006

 

Principal Investigator of a Phase II, 28-day, Partially Blinded, Multicenter, Randomized, Parallel-group Study to Evaluate 200 and 300 ug Daily of a Recombinant Form of Parathyroid Hormone Compared to a Daily Recombinant Form of Parathyroid Hormone on Bone Turnover Markers, Pharmacokinetics, and Safety in Postmenopausal Women. 2006.

 

Principal Investigator of a Multi-Center, Randomized, Double-Blind, Parallel Group, Dose-Finding Trial to Evaluate the Safety and Efficacy of a corticosteroid Combined With a Beta2 agonist in Patients With Chronic Obstructive Pulmonary Disease. 2006.

 

Sub-Investigator of A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of XXX in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma. 2012.

 

Sub-Investigator of A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with XXX Alone or in Combination with XXX  in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection. 2012.

 

Sub-Investigator of A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in XXX-Sponsored Trials in Subjects with Chronic Hepatitis C Infection (SVR Registry). 2012

 

Sub-Investigator of A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in XXX-Sponsored Trials in Subjects with Chronic Hepatitis C Infection. 2012.

 

Sub-Investigator of A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of *** Administered Twice Daily compared with Placebo in Adolescent and Adult Subjects with Persistent Asthma Uncontrolled on Non-steroidal Therapy. 2012.

 

Sub-Investigator of A Double-Blind, Randomized, 3 Period Crossover, Single Ascending Dose Study to Assess the Safety, and Tolerability of Inhaled XXX  in Subjects with Intermittent, or Mild-to-Moderate Persistent, Asthma. 2012.

 

Sub-Investigator of A 2-week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Safety and Efficacy Study of XXX in Subjects 6-11 Years Old. 2012.

 

Sub-Investigator of A dose-ranging study of XXX inhalation powder in children aged 5-11 years with       asthma. 2012.

 

Sub-Investigator of A Phase IIB, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Dosing Regimens of XXX in Adults with Allergic Asthma who are Inadequately Controlled on Inhaled Corticosteroids and a Second Controller. 2012.

 

 

Sub-Investigator of An Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetic Profile of XXX Patch (XXX Transdermal Drug Delivery System) following 24-hr Application in Patients Diagnosed with Parkinson’s Disease. 2012.

 

Sub-Investigator of A Repeat-dose, open-label, parallel-group study to assess the pharmacokinetics of XXX and metabolites in normal subjects and subjects with impaired renal function. 2012.

 

Sub-Investigator of A Single-Dose, Open-label, Multicenter, Parallel Group Study Evaluation of the Safety and Pharmacokinetics of a Single Dose of XXX in Female Subjects with Normal and Impaired Renal Function. 2012.

 

Sub-Investigator of a Phase IV, a Stratified, Multicenter, Randomized, Double-blind, Parallel Group, 4-week Comparison of an Inhaled Steroid/Long-acting Beta Agonist Combination Product 100/50mcg BID Versus an Inhaled Steroid 100mcg Twice a Day in Pediatric Subjects with Activity-Induced Bronchospasm. 2006

 

Sub-Investigator of a Phase III, Double-Blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of XXXX Biological Herpes Simplex Candidate Vaccine (XXXX) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10 – 17 Years. 2006.

 

Sub-Investigator of a Phase IV Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, who Have Either a XXXX, a XXXX or a XXXX Genotype and are Treated With Inhaled Steroid Diskus Combination Product 100/50mcg Twice a Day or an Inhaled Ateroid Diskus 50mcg Twice a day.  2006.

 

Sub-Investigator of a 24-Week Randomized, Double-Blind, Multi-Centre, Active Controlled (pioglitazone) Study to Evaluate the Efficacy, Safety and Tolerability of Tesaglitazar Therapy when Administered to Patients with Type 2 Diabetes. 2006

 

Sub-Investigator of a Phase IV Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving an Inhaled Corticosteroid 100/50mcg Diskus twice a day or inhaled corticosteroid 100mcg Diskus twice a Day. 2006

 

Sub-Investigator of a Double-Blind, Multi-Center Active-Controlled, (pioglitazone) Long Term Extension Study to Evaluate the Safety and Tolerability of a Thiazolidinedione in Patients with Type 2 Diabetes Mellitus. 2006.

 

Sub-Investigator of a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-daily, Intranasal Administration of XXXX Aqueous Nasal Spray 50mcg and 100mcg for 2 weeks in Pediatric Subjects Ages 2 to  <12 Years with Seasonal Allergic Rhinitis (SAR). 2006

 

Sub-Investigator of a Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Aqueous Nasal Spray 200mcg QD versus an oral leukotriene receptor antagonist10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving an Inhaled steroid by Diskus 100/50mcg BID or Placebo BID.  2006.

 

Sub-Investigator of a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of XXXX Inhalation Powder 200mcg Twice-Daily, XXXX Inhalation Powder 200mcg Once-Daily, and XXXX Inhalation Powder 400mcg Once-Daily in the Morning Compared with Placebo for 8 Weeks in Adolescent and Adult Subjects (12 Years of Age and Older) with Persistent Asthma Symptomatic on Low-Dose ICS Therapy. 2006

 

Sub-Investigator of a Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of Ariflo (15mg BID) in Patients with Chronic Obstructive Pulmonary Disease (COPD). 2006.

 

Sub-Investigator of a Placebo- and Active-controlled (Ciclesonide Metered Dose Inhaler), Randomized, Parallel-group, Dose-range Finding study of Ciclesonide Administered by Dry Inhaler In Adult and Adolescent Patients With Persistent Asthma.  2006.

 

Sub-Investigator of Phase III Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects with Mixed Dyslipidemia. 2006.

 

Sub-Investigator of a Phase III Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and Statin Therapy for Subjects with Mixed Dyslipidemia. 2006

 

Sub-Investigator of a Phase III Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Tolerability of an inhaled steroid (200 mcg Once Daily), Applied as a Nasal Spray for Twelve Weeks, in the Treatment of Perennial Allergic Rhinitis (PAR) in Pediatric Patients 2-5 Years of Age. 2006

 

Sub-Investigator of a Long-Term, Post-treatment, Safety Follow-up, Multi-Centre Study in Patients with Type 2 Diabetes Mellitus from the XXX, XXX or XXX studies. XXXX Post treatment Long-term follow-Up Study.  2006

 

Sub-Investigator of a Phase III Multi-center, Randomized, Open‑label Study to Assess the Functionality of an Oral Steroid With an Actuation Counter During use by Children, Adolescents, and Adults With Stable, Inhaled Corticosteroid‑dependent Asthma. 2006

 

Sub-Investigator of a Phase IIIB Short-Term (8-Week) Open-Label Study, Followed By A Long-Term Evaluation, To Assess Patient Satisfaction With a dopamine reuptake inhibitor Treatment (150 to 250 mg/day) For Excessive Sleepiness In Adults With Narcolepsy Or Obstructive Sleep Apnea/ Hypopnea Syndrome (OSAHS). 2006.

 

Sub-Investigator of a Phase IIIB Double-Blind, Randomized, Placebo-Controlled, Dose-Comparison Study of Subcutaneous Hydration with and without Human Recombinant Hyaluronidase in Volunteer Subjects. 2006.

 

Sub-Investigator of a Phase III Multicenter, Double-Blind, Active-Controlled, Parallel Design Study to Assess the Efficacy, Safety and Pharmacokinetics of a bone resorption inhibitor Upon Multiple Dose Oral Administration of a 35 mg Delayed-Release, a 50 mg Delayed-Release or a 35 mg Immediate-Release Formulation Administered Weekly for 13 Weeks to Postmenopausal Women.  2006.

 

Sub-Investigator of A Phase II Randomized, Double-blind, placebo-controlled multicenter proof of concept trial of XXX in subjects with nonrestorative sleep. 2006.

 

Sub-Investigator of a Phase III multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of an oral steroid metered-dose inhaler at a daily dose of 160 µg administered either in a once-daily in the morning regimen(160 µg qd AM) for 16 weeks or in a 160 µg qd AM regimen for 12 weeks preceded by a twice-daily regimen (80 µg bid) for 4 weeks, or in an 80 µg bid regimen for 16 weeks, in adults and adolescents with mild to moderate persistent asthma not treated with steroids.  2006

 

Sub-Investigator of a Phase III Randomized, Double-blind, Placebo-controlled, Parallel group, Stratified, Multi-center, 12-week study comparing the Safety and Efficacy of an Oral steroid Combination (XXX 100/10ug or 250/10ug twice daily) in a Single Inhaler (XXXHFA p MDI) With the Administration of Placebo or Inhaled Steroid (250ug twice daily) and an Oral Steroid Alone in Adolescent and Adult Patients with Moderate to Severe Asthma. 2006.

 

Sub-Investigator of a Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Proof-of-Concept Study to Evaluate the Safety and Efficacy of a melatonin receptor agonist Taken in Combination with an Anti-convulsant for the Treatment of Subjects with Chronic Insomnia. 2006.

 

Sub-Investigator ofa Phase III 28-Day, Multi-Center, Randomized, Placebo-Controlled, Double-Blind Study of anti-anxiety agent in Healthy Subjects and Patients with Generalized Anxiety Disorder. 2006.

 

Sub-Investigator of a Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Epidemiology of Natural Infection with Enterotoxigenic Escherichia coli Occurring after Transcutaneous Immunization in a Field Setting. 2006

 

Sub-Investigator of an Eight Week, Randomized, Double-Blind, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of Oral XXX to Placebo in Subjects with Moderate to Severe Persistent Asthma Inadequately Controlled on Inhaled Corticosteroids. 2006.

 

Sub-Investigator of a Study on the Effects of a biphasic insulin aspart Mix 70/30 BID and QD vs. an incretin mimetic (exenatide) BID on Glycemic Control: A Multicenter, 24-Week, Open-Label, Parallel Group Study in Patients with Type 2 Diabetes Mellitus not Achieving Glycemic Targets with an anti-diabetic drug  and another anti-diabetic drug. 2006.

 

Sub-Investigator of a 12-Week Efficacy and Safety Study of Two Doses of a glucocorticoid steroid/long acting B2 agonist Combination Formulation Compared With glucocorticoid Monotherapy, in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids. 2006

 

Sub-Investigator of  a Multiple-center, Open-label, Multiple-dose, Three period, Single -sequence, Crossover Study to Investigate the Potential Pharmacodynamic and Potential Pharmacokinetic Interaction between an Anti-diabetic Drug and XXX in Type 2 diabetic Patients Not Adequately Controlled with Anti-diabetic Drug as a Standard Prescribed Therapy. 2006

 

Sub-Investigator of a Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of XXX in Patients with Seasonal Allergic Rhinitis. 2006.

 

Sub-Investigator of a Randomized, Double-Blind, Parallel Group Study Evaluating the Safety of Corticosteroid/Long-acting B2-adrenergic Receptor Agonist Drug 100/50mcg HFA (2 inhalations of 50/25mcg) Twice Daily Compared With a Corticosteroid 100mcg HFA (2 inhalations of 50mcg) Twice Daily in Subjects 4-11 Years of Age with Persistent Asthma. 2006.

 

Sub-Investigator of an Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of XXX Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of XXX Administered in the Abdomen of Healthy, Normal Volunteers. 2006.

 

Sub-Investigator of A Phase IIIb, Randomized, Open, Multi-center Study to Evaluate the Safety and Immunogenicity of XXX Vaccine Co-administered Intramuscularly with  Vaccine and/or XXX Vaccine, According to Different Dose Schedule Combinations as Compared to the Administration of HPV vaccine,  XXX or XXX Alone in Healthy Female Subjects Aged 11-18 years. 2006.

 

Sub-Investigator for A Study on Efficacy and Safety of Combination of Two Study Medication  and Placebo in Treatment of Subjects with Seasonal Allergic Rhinitis. 2005.

 

Sub-Investigator for Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Once-daily, Intranasal Administration of an Aqueous  Nasal Spray 50mcg and 100mcg for 12 Weeks in Pediatric Subjects Ages 2 to 12 Years Old With Perennial Allergic Rhinitis.  2005.