At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 50 enrolled
Drug / intervention
Paroxetine HCl +1 moredrug
Likely dose
Paroxetine HCl 40 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.
Randomized, 2-Way Crossover, Bioequivalence Study of Paroxetine Hydrochloride 40 mg Film-Coated Tablets and Paxil® 40 mg Film-Coated Tablets Administered as 1 x 40 mg Film-Coated Tablet in Healthy Subjects Under Fasting Conditions
In Brief
A Phase 1 clinical trial evaluating Paroxetine HCl and Paxil® for Healthy. Completed, enrolled 50 participants across 1 site.
Detailed Summary
The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 40 mg film-coated tablets (test) versus Paxil® (reference) administered as 1 x 40 mg film-coated tablet under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2002
Primary CompletionOct 2002
First PostedFeb 2009
TodayJul 2026
First PostedFeb 11, 2009
Enrollment StartOct 1, 2002
Primary CompletionOct 1, 2002
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago
Interventions
Paroxetine HCldrug
40 mg Film-Coated Tablet
Paxil®drug
40 mg Film-Coated Tablet