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

Phase 1

Completed

Conditions: Prostatic Hyperplasia

Interventions: Drug: Test formulation
Drug: Reference formulation

Registration Number: NCT01262989

Lead Sponsor: GlaxoSmithKline

Brief 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tamsulosin Reference	Test formulation	Reference drug administration followed by Test drug administration
tamsulosin Reference	Reference formulation	Reference drug administration followed by Test drug administration
tamsulosin Test	Test formulation	Test drug administration followed by Reference drug administration
tamsulosin Test	Reference formulation	Test drug administration followed by Reference drug administration

Primary Outcome Measures

Name	Time	Method
AUC0-infinity	Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)	The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to infinity (the time of complete elimination of the drug) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption.
AUC0-t	Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)	The area under the plot of plasma concentration of drug against time after drug administration is defined as the area under the curve (AUC). The AUC from time 0 (prior to administration of medication) to time t (the time of the last quantifiable concentration) was calculated using the trapezoidal method. This method consists of the sum of the trapezoids' areas, determined by the collection times and their concentrations. The AUC is of particular use in estimating the bioavailability of drugs, by measuring the extent of absorption. ng, nanograms; ml, milliliter.
Cmax	Days 1 to 3 (Period 1) and Days 9 to 11 (Period 2)	Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating bioavailability of drugs, by measuring the total amount of drug absorbed.