Overview

Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition

Status:
Completed
Trial end date:
2001-09-01
Target enrollment:
0
Participant gender:
Male
Summary
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Isotretinoin
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.