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Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01888224
Recruitment Status : Completed
First Posted : June 27, 2013
Last Update Posted : June 27, 2013
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Last Update Posted Date June 27, 2013
Study Start Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2013)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition
Official Title  ICMJE 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.
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Isotretinoin
Isotretinoin Capsules,40 mg
Study Arms  ICMJE
  • Experimental: Isotretinoin capsules, 40 mg
    Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd
    Intervention: Drug: Isotretinoin
  • Active Comparator: AMNESTEEM
    AMNESTEEM 40 mg of Mylan Pharmaceuticals Inc
    Intervention: Drug: Isotretinoin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2013)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01888224
Other Study ID Numbers  ICMJE 618-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Alpeshkumar Patel, MD Lambda Therapeutic Research Limited
PRS Account Dr. Reddy's Laboratories Limited
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP