CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 60 enrolled
Drug / intervention
Test formulation +1 moredrug
Likely dose
Reference formulation 25 mgfrom 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/NCT01316926
NCT01316926Phase 1Completed
CompareCT.gov

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

GlaxoSmithKline·interventional·Posted Mar 16, 2011·Updated Jun 20, 2018

In Brief

A Phase 1 clinical trial evaluating Test formulation and Reference formulation 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 drug test and reference (two periods of drug administration).

Study Details

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

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 16, 2011
Enrollment StartSep 9, 2009
Primary CompletionOct 5, 2009
TodayJul 2, 2026
Enrollment to primary: 26 daysPosted 15.3 years ago

Interventions

Test formulationdrug

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

Reference formulationdrug

Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)