Status:
COMPLETED
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 fed condi...
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 fed conditions
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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).
- Exclusion Criteria
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2001
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01888328
Start Date
May 1 2001
End Date
June 1 2001
Last Update
June 27 2013
Active Locations (1)
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1
AAI
Quadrangle Drive, Chapel Hill,, North Carolina, United States, 27514