NCT01330303

SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed 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 Healthy Male Volunteers Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (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 volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.

Detailed description

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. 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	Reference formulation	SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)
DRUG	Test formulation	tamsulosin hydrochloride 0,4 mg (Synthon BV)

Timeline

• Start date: 2009-12-08
• Primary completion: 2009-12-22
• Completion: 2009-12-22
• First posted: 2011-04-06
• Last updated: 2017-08-01
• Results posted: 2011-04-06

Locations

1 site across 1 country: Brazil