Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2001-06-30

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

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isotretinoin capsules, 40 mg

Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd

Group Type EXPERIMENTAL

Isotretinoin

Intervention Type DRUG

Isotretinoin Capsules,40 mg

ACCUTANE

ACCUTANE 40 mg of Roche Laboratories Inc

Group Type ACTIVE_COMPARATOR

Isotretinoin

Intervention Type DRUG

Isotretinoin Capsules,40 mg

Interventions

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Isotretinoin

Isotretinoin Capsules,40 mg

Intervention Type DRUG

Other Intervention Names

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ACCUTANE

Eligibility Criteria

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Inclusion Criteria

1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. 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

1. Hypersensitivity to isotretinoin or related compounds.
2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
3. Recent history of mental illness, drug addiction, drug abuse or alcoholism.
4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
5. Received an investigational drug within the 4 weeks prior to study dosing.
6. 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.
7. Regular tobacco use in the 3 months prior to study dosing.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes