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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Prostatic Hyperplasia

Treatments: Drug: tamsulosin HCl; Drug: tamsulosin capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT02417831

527.88

Details and patient eligibility

About

A bio-equivalence of 2 different capsule formulations in fasted subjects

Enrollment: 34 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male volunteers 18 years and older

Exclusion criteria

History of hypersensitivity or allergy to the IPM 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 capsules

Active Comparator group

Treatment:

Drug: tamsulosin capsules

tamsulosin HCl capsules

Active Comparator group

Treatment:

Drug: tamsulosin HCl