Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition
Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Isotretinoin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Dr. Reddy's Laboratories Limited Official(s) and/or principal investigator(s): Dr. Ralph Scallion , MD, Principal Investigator, Affiliation: AAI
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 conditions
Clinical Details
Official title: An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANEŽ Capsules 40 mg of Roche Laboratories Inc., Under Fasting Conditions
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Area under curve (AUC)
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 fasting conditions
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Healthy males between 18 and 45 years of age inclusive.
2. Informed of the nature of the study and given written informed consent.
3. 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
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.
Locations and Contacts
AAI, Quadrangle Drive, Chapel Hill,, North Carolina 27514, United States
Additional Information
Starting date: July 2001
Last updated: June 26, 2013
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