Status:
COMPLETED
Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting 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 fasting c...
Detailed Description
An open label, randomized, single dose, oral bioequivalence study of Isotretinoin capsules 20 mg of Dr. Reddy's Laboratories Limited,under fasting 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 :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2002
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01888341
Start Date
August 1 2002
End Date
August 1 2002
Last Update
June 27 2013
Active Locations (1)
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1
AAI
Quadrangle Drive, Chapel Hill,, North Carolina, United States, 27514