At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Venlafaxine Hydrochloride +1 moredrug
Likely dose
Venlafaxine Hydrochloride 150 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 Venlafaxine Hydrochloride 150 mg Extended-Release Capsules and Effexor® XR 150 mg Extended-Release Capsules Administered as the Content of 1 x 150 mg Extended-Release Capsule Mixed With Applesauce in Healthy Subjects Under Fasting Conditions.
In Brief
A Phase 1 clinical trial evaluating Venlafaxine Hydrochloride and Effexor® XR for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed Summary
The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2003
Primary CompletionMar 2003
First PostedJan 2011
TodayJul 2026
First PostedJan 25, 2011
Enrollment StartFeb 1, 2003
Primary CompletionMar 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.4 years ago
Interventions
Venlafaxine Hydrochloridedrug
150 mg Extended-Release Capsule
Effexor® XRdrug
150 mg Extended-Release Capsule