Trial | NCT01888328  Report issue

Title

Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
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 ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fed Conditions

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    26
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
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
Study Started
May 31
2001
Primary Completion
May 31
2001
Study Completion
Jun 30
2001
Last Update
Jun 27
2013
Estimate

Drug Isotretinoin

Isotretinoin Capsules,40 mg

  • Other names: ACCUTANE

Isotretinoin capsules, 40 mg Experimental

Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd

ACCUTANE Active Comparator

ACCUTANE 40 mg of Roche Laboratories Inc

Criteria 

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.
No Results Posted