Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT01888328

Run by

Dr. Reddy's Laboratories Limited

People needed

26

Starts

2001-05-01

Expected to finish

2001-06-01

Last updated by the study team

2013-06-27

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Healthy males between 18 and 45 years of age inclusive.
• Informed of the nature of the study and given written informed consent.
• 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).

You may not qualify if…

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

Where it is running

• AAI — Quadrangle Drive, Chapel Hill,, North Carolina, United States

Full record on ClinicalTrials.gov

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