Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting 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 Fasting Conditions

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Isotretinoin

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Quadrangle Drive, Chapel Hill,, North Carolina, United States, 27514
      • AAI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Isotretinoin capsules, 40 mg; Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd	Drug: Isotretinoin; Isotretinoin Capsules,40 mg; Other Names: ACCUTANE
Active Comparator: ACCUTANE; ACCUTANE 40 mg of Roche Laboratories Inc	Drug: Isotretinoin; Isotretinoin Capsules,40 mg; Other Names: ACCUTANE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (Actual): August 1, 2001
• Study Completion (Actual): September 1, 2001

Study Registration Dates

• First Submitted: June 25, 2013
• First Submitted That Met QC Criteria: June 26, 2013
• First Posted (Estimate): June 27, 2013

Study Record Updates

• Last Update Posted (Estimate): June 27, 2013
• Last Update Submitted That Met QC Criteria: June 26, 2013
• Last Verified: November 1, 2001

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Isotretinoin
• Other Study ID Numbers: AAI-US-101