At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
Test formulation +1 moredrug
Likely dose
Test 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 (Boehringer Ingelheim) in Healthy Male Volunteers Under Fasting Conditions.
In Brief
A Phase 1 clinical trial evaluating Test formulation and Reference formulation for Prostatic Hyperplasia. Completed, enrolled 40 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 healthy male volunteers under fasting conditions receive, in each period, the test formulation or the reference formulation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Hyperplasia
CountriesBrazil
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2010
Primary CompletionJan 2010
First PostedDec 2010
TodayJul 2026
First PostedDec 20, 2010
Enrollment StartJan 4, 2010
Primary CompletionJan 26, 2010
TodayJul 2, 2026
Enrollment to primary: 22 daysPosted 15.5 years ago
Interventions
Test formulationdrug
tamsulosin hydrochloride 0,4 mg (Synthon BV)
Reference formulationdrug
tamsulosin 0,4 mg (Boehringer Ingelheim)