NCT01262989

SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

TITLE: Randomized, two-period, cross-over, bioequivalence study on tamsulosin hydrochloride 0,4 mg prolonged release hard gelatin capsule (Synthon BV, The Netherlands) versus SECOTEX® (tamsulosin hydrochloride) 0,4 mg prolonged release hard gelatin capsule (Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda) in healthy male volunteers under fasting conditions. 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. The treatment's sequence attributed to each volunteer on the study period is determined by a randomization list, which is generated by PROC PLAN from SAS version 9.1.3 system. The formulations will be administered as a single oral dose followed by blood collections between, at least, 3 to 5 half-lives. The treatment's periods may obey a minimum interval of 7 half lives between them (period for drug's whole elimination by the organism).

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Test formulation	tamsulosin hydrochloride 0,4 mg (Synthon BV)
DRUG	Reference formulation	tamsulosin 0,4 mg (Boehringer Ingelheim)

Timeline

• Start date: 2010-01-04
• Primary completion: 2010-01-26
• Completion: 2010-01-26
• First posted: 2010-12-20
• Last updated: 2017-08-14
• Results posted: 2011-03-31

Locations

1 site across 1 country: Brazil