Healthy Volunteers Clinical Trial
Official title:
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
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.
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).
;
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
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