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

Phase 1

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: tamsulosin HCl; Drug: tamsulosin capsules

• Registration Number: NCT02417831
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Study Start: 2015-04-30
• Primary Completion: 2015-05-31
• Study Completion: 2015-05-31
• Results First Submitted: 2020-03-12
• Results First Submitted QC: 2020-03-12
• Results First Posted: 2020-03-26
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tamsulosin HCl capsules	tamsulosin HCl	-
tamsulosin capsules	tamsulosin capsules	-

Primary Outcome Measures

Name	Time	Method
Cmax	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.	Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
AUC0-tz	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).; Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
(AUC0-inf)	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.	Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).; Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.

Secondary Outcome Measures

Name	Time	Method
Tmax	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.	Time to maximum plasma concentration
λz	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.	Terminal elimination rate constant in plasma (λz).; Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
t1/2	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.	Apparent terminal elimination half-life of the analyte in plasma (t1/2); Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.