Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Prostatic Hyperplasia

Treatments: Drug: Tamsulosin HCL; Drug: tamsulosin (Astellas)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02417844

527.89

Details and patient eligibility

About

Two tamsulosin HClformulations will be tested in fed state

Enrollment: 34 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Health male volunteers 18 years and older

Exclusion criteria

History of hypersensitivity or allergy to IMP or its excipients or any related medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Tamsulosin HCl

Active Comparator group

Treatment:

Drug: Tamsulosin HCL

Tamsulosin

Active Comparator group

Treatment:

Drug: tamsulosin (Astellas)