Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fed Condition

ClinicalTrials.gov ID: NCT01888328

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Official title

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 Fed Conditions

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 fed conditions

Study identification

NCT ID: NCT01888328
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Dr. Reddy's Laboratories Limited, India; Industry
Enrollment: 26 participants

Conditions and interventions

Conditions

Healthy

Interventions

Isotretinoin Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Male
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 2001 (Type not available)
Primary completion: May 2001 (Actual)
Completion: Jun 2001 (Actual)
Last update posted: Jun 27, 2013

2001

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
AAI	Quadrangle Drive, Chapel Hill,	North Carolina	27514	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01888328, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jun 27, 2013 · Synced Nov 15, 2026