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Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Isotretinoin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Dr. Ralph Scallion , MD, Principal Investigator, Affiliation: AAI


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

Clinical Details

Official title: 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 ACCUTANEŽ Capsules 40 mg of Roche Laboratories Inc., Under Fasting Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under curve (AUC)

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


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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.

Locations and Contacts

AAI, Quadrangle Drive, Chapel Hill,, North Carolina 27514, United States
Additional Information

Starting date: July 2001
Last updated: June 26, 2013

Page last updated: August 23, 2015

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