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

Phase 1

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: tamsulosin (Astellas); Drug: Tamsulosin HCL

• Registration Number: NCT02417844
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Two tamsulosin HClformulations will be tested in fed state

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2020-03-12
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Results First Posted: 2020-04-17
• Last Update Posted: 2020-04-17

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	tamsulosin (Astellas)	-
Tamsulosin HCl	Tamsulosin HCL	-

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax)	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Maximum measured concentration of analyte in plasma (Cmax)
Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 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)
Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 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).

Secondary Outcome Measures

Name	Time	Method
Time to Maximum Plasma Concentration (Tmax)	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Time from last dosing to the maximum plasma concentration (tmax).
Terminal Elimination Rate Constant (λz)	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Terminal elimination rate constant in plasma (λz)
Apparent Terminal Elimination Half-life (t1/2)	Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration	Apparent terminal elimination half-life of the analyte in plasma (t1/2)