CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico +1 moredrug
Likely dose
Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Ricofrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01339247
NCT01339247Phase 1Completed
CompareCT.gov

Relative Bioavailability Study Between the Formulations: Paroxetine 25 mg Tablets With Controlled Release Manufactured by GSK Mississauga and Paroxetine 25 mg Tablets With Controlled Release Manufactured by SmithKline Beecham (Cidra), Fed Administration in Healthy Volunteers of Both Genders

GlaxoSmithKline·interventional·Posted Apr 20, 2011·Updated Jun 20, 2018

In Brief

A Phase 1 clinical trial evaluating Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico and Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada for Depressive Disorder. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The study is prospective, open, randomized, crossover in steady state and the volunteers received multiple doses of the test drug and the reference drug (two periods of drug administration after standardized meals).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Disorder
CountriesBrazil
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2011
Enrollment StartOct 20, 2009
Primary CompletionNov 16, 2009
TodayJul 2, 2026
Enrollment to primary: 26 daysPosted 15.2 years ago

Interventions

Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Ricodrug

Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canadadrug

Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)