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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00406003 |
The study was designed to describe the relationship between dose and pharmacokinetic parameters of paroxetine over the range of proposed dosage strengths of the paroxetine CR tablet (12.5 to 37.5 mg) as well as safety profile
Condition | Intervention | Phase |
---|---|---|
Pharmacokinetics |
Drug: Paroxetine controlled Release 12.5mg, 25mg and37.5mg |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | A Randomized, Open, Three-Period Crossover Study to Compare the Pharmacokinetic Profile of Paroxetine After Single Dosing of Each Enteric-Coated Geomatrix Control Release Tablet Strength (12.5, 25, 37.5mg) in Healthy Chinese Subjects |
Estimated Enrollment: | 12 |
Study Start Date: | March 2006 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 19 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | PCR104074 |
Study First Received: | November 30, 2006 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00406003 |
Health Authority: | China: State Food and Drug Administration |
BRL029060/Paroxetine CR pharmacokinetics safety |
Healthy Paroxetine Serotonin |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Antidepressive Agents, Second-Generation Central Nervous System Agents Serotonin Uptake Inhibitors Antidepressive Agents Pharmacologic Actions |