PAXIL CR Bioequivalence Study

Phase 1

Completed

• Conditions: Depressive Disorder
• Interventions: Drug: Paxil CR

• Registration Number: NCT00749359
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study is to determine if controlled release paroxetine tablets manufactured at two different sites behave similarly in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-07
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-09
• Primary Completion: 2008-09-16
• Study Completion: 2008-09-16
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
open label treatment	Paxil CR	On each treatment period, subjects will receive controlled release paroxetine 37.5 milligram (mg) on Day 1.

Primary Outcome Measures

Name	Time	Method
Paroxetine blood levels	measured up to 168 hours after a single dose.

Secondary Outcome Measures

Name	Time	Method
Additional pharmacokinetic parameters related to blood levels of paroxetine . Safety & tolerability measures including ae reporting & vitals signs & ECGs	measured up to 168 hours after a single dose and throughout study

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Tacoma, Washington, United States