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
1 other identifier
interventional
35
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Jul 2001
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 25, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedJune 27, 2013
November 1, 2001
1 month
June 25, 2013
June 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Isotretinoin capsules, 40 mg
EXPERIMENTALIsotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
ACCUTANE
ACTIVE COMPARATORACCUTANE 40 mg of Roche Laboratories Inc
Interventions
Isotretinoin Capsules,40 mg
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AAI
Quadrangle Drive, Chapel Hill,, North Carolina, 27514, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Ralph Scallion, MD
AAI
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2013
First Posted
June 27, 2013
Study Start
July 1, 2001
Primary Completion
August 1, 2001
Study Completion
September 1, 2001
Last Updated
June 27, 2013
Record last verified: 2001-11