Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00625859 |
The purpose of this research study is to look at concentrations of GSK189075, WELLBUTRIN SR and active metabolic products in blood samples when doses of both drugs are taken by mouth. Doses are either taken alone or together. The results will help to determine if doses of GSK189075 and WELLBUTRIN SR can be safely taken together.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects |
Drug: GSK189075 Drug: bupropion Drug: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Double-Blind, Randomized, 6-Sequence, 3-Period Crossover Drug-Drug Interaction Study to Evaluate the Pharmacokinetics of WELLBUTRIN SR (Bupropion) and GSK189075 When co-Administered or Administered Alone in Healthy Male Volunteers |
Estimated Enrollment: | 30 |
Study Start Date: | January 2008 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
General
Clinically significant abnormalities at Screening including:
QTC Interval (Bazett) > 450 ms
= exp(5.228-1.154 x ln (SCr)-0.203x ln(age)-(0.299 if female) + (0.192 if African American))
Central Nervous System
Note: A single childhood febrile seizure is not exclusionary.
Hepatic and Gastrointestinal systems
Endocrine system
Cardiac system
Drugs and Alcohol
Subject has a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation in this study.
• Concomitant medications usage that includes:
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days prior to the first dose in Treatment Period 1, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | KGW111083 |
Study First Received: | February 19, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00625859 |
Health Authority: | United States: Food and Drug Administration |
Healthy adult male volunteers, pharmacokinetics, pharmacodynamics |
Dopamine Bupropion Healthy |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |