Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition

Dr.Reddy's Laboratories

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Isotretinoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01888341

AAI-US-129

Details and patient eligibility

About

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 fasting conditions

Full description

An open label, randomized, single dose, oral bioequivalence study of Isotretinoin capsules 20 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Enrollment: 41 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Isotretinoin capsules, 20 mg

Experimental group

Description:

Isotretinoin Capsules, 20 mg of Dr.Reddy's Laboratories Ltd

Treatment:

Drug: Isotretinoin

ACCUTANE

Active Comparator group

Description:

ACCUTANE 20 mg of Roche Laboratories Inc

Treatment:

Drug: Isotretinoin