Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting 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 fasting conditions
Key facts
- Study ID
- NCT01888289
- Run by
- Dr. Reddy's Laboratories Limited
- People needed
- 35
- Starts
- 2001-07-01
- Expected to finish
- 2001-09-01
- 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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