Bioequivalence Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg Under Fed Condition

Study Overview
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Brief Summary
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The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®) 1 mg finasteride tablets under fed conditions following administration of a 3 mg dose.

Detailed Description
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Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each period, subjects were housed from the evening before dosing until after the 36-hour blood draw. Single oral 3 mg doses were separated by a washout period of 7 days.

Official Title
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Comparative,Randomized,Single-dose,2-way Crossover Bioavailability Study of Dr.Reddy's Laboratories Limited Finasteride Tablets 1 mg and Merck & Co., Propecia in Healthy Adult Males Under Fed Condition.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Finasteride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Exclusion Criteria: History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to finasteride or any other 5-a reductase inhibitor. Subjects who have been on an abnormal diet (for whatever reason) during the 28 days preceding the study. Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days, or 500 - 750 mL of blood in 14 days (unless approved by the Principal Investigator), 1000 mL of blood in 90 days, 1250 mL of blood in 120 days, 1500 mL of blood in 180 days, 2000 mL of blood in 270 days, 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days prior to the first dosing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Experimental: Finasteride<br>Finasteride tablets 1 mg of Dr. Reddy's | Drug: Finasteride<br>* Finasteride tablets 1 mg<br>* Other names: Propecia;|
| Active Comparator: Propecia<br>Propecia 1 mgTablets of Merck & Co., | Drug: Finasteride<br>* Finasteride tablets 1 mg<br>* Other names: Propecia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on Cmax and AUC parameters |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioequivalence,Finasteride,Crossover