Back to resultsBioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
About this trial
This is an interventional treatment trial for Healthy
Eligibility 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.
Sites / Locations
- AAI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Isotretinoin capsules, 40 mg
ACCUTANE
Arm Description
Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
ACCUTANE 40 mg of Roche Laboratories Inc
Outcomes
Primary Outcome Measures
Area under curve (AUC)
Secondary Outcome Measures
Full Information
NCT ID
NCT01888328
First Posted
June 25, 2013
Last Updated
June 26, 2013
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT01888328
Brief Title
Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
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 ACCUTANE® Capsules 40 mg of Roche Laboratories Inc., Under Fed Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2001
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
May 2001 (Actual)
Study Completion Date
June 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 fed 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 fed conditions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isotretinoin capsules, 40 mg
Arm Type
Experimental
Arm Description
Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
Arm Title
ACCUTANE
Arm Type
Active Comparator
Arm Description
ACCUTANE 40 mg of Roche Laboratories Inc
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Other Intervention Name(s)
ACCUTANE
Intervention Description
Isotretinoin Capsules,40 mg
Primary Outcome Measure Information:
Title
Area under curve (AUC)
Time Frame
Pre-dose (0) and 0.5, 1,1.5,2,2.5,3,4,5,6,7,8,11,14,18, 24,36,48,72 and 96 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Ralph Scallion, MD
Organizational Affiliation
AAI
Official's Role
Principal Investigator
Facility Information:
Facility Name
AAI
City
Quadrangle Drive, Chapel Hill,
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
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Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition
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