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

NCT ID: NCT02417831

Last Updated: 2020-04-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tamsulosin capsules

Group Type ACTIVE_COMPARATOR

tamsulosin capsules

Intervention Type DRUG

tamsulosin HCl capsules

Group Type ACTIVE_COMPARATOR

tamsulosin HCl

Intervention Type DRUG

Interventions

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tamsulosin capsules

Intervention Type DRUG

tamsulosin HCl

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Other Identifiers

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527.88

Identifier Type: -

Identifier Source: org_study_id

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