At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
Tamsulosin +1 moredrug
Likely dose
Tamsulosin 0.4 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.
A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Tamsulosin for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--
Timeline
Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2004
Primary CompletionNov 2004
First PostedJun 2010
TodayJul 2026
First PostedJun 23, 2010
Enrollment StartNov 1, 2004
Primary CompletionNov 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 16.0 years ago
Interventions
Tamsulosindrug
Test 0.4 mg Capsule
Tamsulosindrug
Reference Listed 0.4 Capsule