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Bioavailability Study of Isotretinoin Capsules 40 mg Under Fed Condition

NCT01888224 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2013-06-27

No results posted yet for this study

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

Interventions

DRUG

Isotretinoin

Isotretinoin Capsules,40 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr. Alpeshkumar Patel, MD · Lambda Therapeutic Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01888224 on ClinicalTrials.gov