Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetics and bioequivalence of isotretinoin formulations after administration of single doses to normal, non-smoking,healthy males under fed conditions

Detailed Description
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An open label, randomized, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fed conditions

Official Title
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An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fed Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Isotretinoin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males between 18 and 45 years of age inclusive. Informed of the nature of the study and given written informed consent. Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I). Exclusion Criteria Hypersensitivity to isotretinoin or related compounds. Any history of a clinical condition which might affect drug absorption, metabolism or excretion. Recent history of mental illness, drug addiction, drug abuse or alcoholism. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. Received an investigational drug within the 4 weeks prior to study dosing. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. Regular tobacco use in the 3 months prior to study 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: Isotretinoin capsules, 40 mg<br>Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd | Drug: Isotretinoin<br>* Isotretinoin Capsules,40 mg<br>* Other names: ACCUTANE;|
| Active Comparator: ACCUTANE<br>ACCUTANE 40 mg of Roche Laboratories Inc | Drug: Isotretinoin<br>* Isotretinoin Capsules,40 mg<br>* Other names: ACCUTANE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve (AUC) |  | Pre-dose (0) and 0.5, 1,1.5,2,2.5,3,4,5,6,7,8,11,14,18, 24,36,48,72 and 96 hours |