Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition

NCT01888224 | Completed Phase 1 DMC

• 1 other identifier: 618-10
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  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

Study Arms (2)

Isotretinoin capsules, 40 mg

EXPERIMENTAL

Isotretinoin Capsules, 40 mg of Dr.Reddy's Laboratories Ltd

Drug: Isotretinoin

AMNESTEEM

ACTIVE COMPARATOR

AMNESTEEM 40 mg of Mylan Pharmaceuticals Inc

Drug: Isotretinoin

Interventions

Isotretinoin DRUG

Isotretinoin Capsules,40 mg

Also known as: AMNESTEEM

AMNESTEEM; Isotretinoin capsules, 40 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Lambda Therapeutic Research Ltd.,

Ahmedabad, Gujarat, 380 061, India

Location

MeSH Terms

Interventions

Isotretinoin

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Dr. Alpeshkumar Patel, MD

  Lambda Therapeutic Research Limited

  PRINCIPAL INVESTIGATOR

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: June 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 27, 2013

Record last verified: 2011-08

Locations

IN (1)