Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

Study Overview
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Brief Summary
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The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical Co., Japan; distributed by Boehringer Ingelheim Pharmaceutical Inc. USA), after a single-dose in healthy subjects under fed conditions.

Official Title
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A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tamsulosin
* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking male subjects, 18 years of age or older. BMI greater than or equal to 19 and less than or equal to 30. Negative for: HIV. Hepatitis B surface antigen and Hepatitis C antibody. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). Urine cotinine test No significant diseases or clinically significant findings in a physical examination. No clinically significant abnormal laboratory values. No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG). Systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 60-90 mmgHg. Be informed of the nature of the study and given written consent prior to receiving any study procedure. Exclusion Criteria: Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration. Known or suspected carcinoma. Known history or presence of: Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity. Alcoholism within the last 12 months. Drug dependence and/or substance abuse. Use of tobacco or nicotine-containing products within the last 6 months. Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing. Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing. On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet). Participated in another clinical trial or received and investigational product within 30 days prior to drug administration. Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation. Difficulty fasting or consuming the standard meals. Do not tolerate venipuncture. Unable to read or sign the ICF.

Ages Eligible for Study
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Minimum Age: 18 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin<br>0.4 mg Capsule | Drug: Tamsulosin<br>* Test 0.4 mg Capsule<br>|
| Active Comparator: Flomax®<br>0.4 mg Capsule | Drug: Tamsulosin<br>* Reference Listed 0.4 Capsule<br>* Other names: Flomax®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Cmax | Blood samples drawn over 60 hour period | 
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on AUC0-t | Blood samples drawn over 60 hour period | 
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on AUC0-inf | Blood samples drawn over 60 hour period |