Conditions: Prostatic Hyperplasia
Keywords: Bioequivalence Healthy volunteers tamsulosin hydrochloride Fed administration
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 37
Healthy volunteers: yes

Brief 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).

Arms:
arm 1: Reference drug administration followed by Test drug administration arm 2: Test drug administration followed by Reference drug administration

Interventions: intervention 1: Reference formulation intervention 2: Test formulation
Intervention descriptions: intervention 1: SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim) intervention 2: tamsulosin hydrochloride 0,4 mg (Synthon BV)

Protocol document: