Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Isotretinoin

• Registration Number: NCT01888289
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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 conditions

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

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2001-08
• Study Completion: 2001-09
• Status Verified: 2001-11
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-26
• Last Update Submitted: 2013-06-26
• Study First Posted: 2013-06-27
• Last Update Posted: 2013-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ACCUTANE	Isotretinoin	ACCUTANE 40 mg of Roche Laboratories Inc
Isotretinoin capsules, 40 mg	Isotretinoin	Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd

Primary Outcome Measures

Name	Time	Method
Area under curve (AUC)	Pre-dose (0) and 0.5, 1,2,3,4,5,6,8,10,16,24,36,48,72 and 96hrs

Trial Locations

Locations (1)

AAI; 🇺🇸 Quadrangle Drive, Chapel Hill,, North Carolina, United States