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

NCT01330303 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-08-01

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 volunteers receive, in each period, the test formulation or the reference formulation, under fed conditions.

Conditions

  • Prostatic Hyperplasia

Interventions

DRUG

Reference formulation

SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)

DRUG

Test formulation

tamsulosin hydrochloride 0,4 mg (Synthon BV)

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
2009-12-08
Primary Completion
2009-12-22
Completion
2009-12-22

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 NCT01330303 on ClinicalTrials.gov