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

NCT01262989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-08-14

Study results available
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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

Conditions

  • Prostatic Hyperplasia

Interventions

DRUG

Test formulation

tamsulosin hydrochloride 0,4 mg (Synthon BV)

DRUG

Reference formulation

tamsulosin 0,4 mg (Boehringer Ingelheim)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-04
Primary Completion
2010-01-26
Completion
2010-01-26

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262989 on ClinicalTrials.gov