At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 37 enrolled
Drug / intervention
Reference formulation +1 moredrug
Likely dose
Reference formulation 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.
Randomized, Two-period, Cross-over, Bioequivalence Study on Tamsulosin Hydrochloride 0,4 mg Prolonged Release Hard Gelatin Capsule Versus SECOTEX® (Tamsulosin Hydrochloride) 0,4 mg Prolonged Release Hard Gelatin Capsule Healthy Male Volunteers Under Fed Conditions
In Brief
A Phase 1 clinical trial evaluating Reference formulation and Test formulation for Prostatic Hyperplasia. Completed, enrolled 37 participants across 1 site.
Detailed Summary
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Hyperplasia
CountriesBrazil
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
Primary CompletionDec 2009
First PostedApr 2011
TodayJul 2026
First PostedApr 6, 2011
Enrollment StartDec 8, 2009
Primary CompletionDec 22, 2009
TodayJul 2, 2026
Enrollment to primary: 14 daysPosted 15.2 years ago
Interventions
Reference formulationdrug
SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)
Test formulationdrug
tamsulosin hydrochloride 0,4 mg (Synthon BV)