Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition

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.