- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888224
Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
June 25, 2013 updated by: Dr. Reddy's Laboratories Limited
Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Isotretinoin Capsules 40 mg of Dr. Reddy's Laboratories Limited, India Comparing With Amnesteem Capsules 40 mg of Mylan Pharmaceuticals Inc., in Healthy, Adult, Male Human Subjects Under Fed Conditions.
To characterise the pharmacokinetic profile of sponsor's test formulation Isotretinoin Capsules 40 mg in comparison to the reference formulation Amnesteem (Containing Isotretinoin) Capsules 40 mg after single oral dose administration to healthy, normal, adult, human male subjects under fed condition.
Study Overview
Detailed Description
An open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, oral bioequivalence study of Isotretinoin Capsules 40 mg under fed conditions.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gujarat
-
Ahmedabad, Gujarat, India, 380 061
- Lambda Therapeutic Research Ltd.,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy adult human male volunteers between 18 to 45 years of age (both inclusive) living in and around Ahmedabad city or western part of India.
- Having a Body Mass Index (BMI) between 18.5-27.5 (both inclusive), calculated as weight in kg / height in meter2.
- Not having any significant disease in medical history or clinically significant abnormal findings during screening, medical history, physical examination,laboratory evaluations, 12- lead ECG and X-ray chest recordings.
- Able to understand and comply with the study procedures, in the opinion of the principal investigator.
- Able to comply to use 2 forms of effective contraception methods simultaneously during Isotretinoin study, and for 1 month after study.
- Able to give voluntary written informed consent for participation in the trial.
- Able to read and/or understand drug medication Guide either in English or in a provided translation when given along with informed consent form.
Exclusion Criteria
- Known hypersensitivity or idiosyncratic reaction to Isotretinoin or any of the excipients including parabens or any related drug.
- History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- Ingestion of any medicine including herbal medicines at any time within 14 days before dosing in Period I. In any such case subject selection will be at the discretion of the Principal Investigator.
- Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAID induced urticaria.
- Use of any recreational drugs or history of drug addiction or testing positive in prestudy drug scans.
- A recent history of harmful use of alcohol(less than 2 years), i.e. alcohol consumption of more than 14 standard drinks per week (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum,whisky, brandy etc) or consumption of alcohol or alcoholic products within 48 hours prior to receiving study medicine.
- Smokers, who smoke 10 or more than 10 cigarettes / day or inability to abstain from smoking during the study.
- The presence of clinically significant abnormal laboratory values during screening.
- History or presence of psychiatric disorders.
- A history of difficulty in donating blood.
- Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication. Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isotretinoin capsules, 40 mg
Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
|
Isotretinoin Capsules,40 mg
Other Names:
|
Active Comparator: AMNESTEEM
AMNESTEEM 40 mg of Mylan Pharmaceuticals Inc
|
Isotretinoin Capsules,40 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under curve (AUC)
Time Frame: Pre-dose (0) and 0.5, 1,1.5,2,2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8,10,12,16,20,24, 36, 48,72 and 96 hrs
|
Pre-dose (0) and 0.5, 1,1.5,2,2.5,3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8,10,12,16,20,24, 36, 48,72 and 96 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dr. Alpeshkumar Patel, MD, Lambda Therapeutic Research Limited
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
June 25, 2013
First Submitted That Met QC Criteria
June 25, 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 25, 2013
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 618-10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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