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

Study Overview
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Brief Summary
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Two tamsulosin HClformulations will be tested in fed state

Official Title
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Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: tamsulosin (Astellas)
* Drug: Tamsulosin HCL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tamsulosin HCl<br> | Drug: Tamsulosin HCL<br> <br> |
| Active Comparator: Tamsulosin<br> | Drug: tamsulosin (Astellas)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Measured Concentration (Cmax) | Maximum measured concentration of analyte in plasma (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 | 
| Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz) | 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) | 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 From 0 Extrapolated to Infinity (AUC0-inf) | Area under the concentration-time curve of analyte in plasma over the time interval 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Plasma Concentration (Tmax) | Time from last dosing to the 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 | 
| Terminal Elimination Rate Constant (λz) | Terminal elimination rate constant in plasma (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 | 
| Apparent Terminal Elimination Half-life (t1/2) | Apparent terminal elimination half-life of the analyte in plasma (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 |