Completed
An Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 20 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 20 mg of Roche Laboratories Inc., Under Fasting Conditions
What is being tested
Isotretinoin
Drug
Who is being recruted
From 18 to 45 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: August 2002
Summary
Principal SponsorDr. Reddy's Laboratories Limited
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2002
Actual date on which the first participant was enrolled.An open label, randomized, single dose, oral bioequivalence study of Isotretinoin capsules 20 mg of Dr. Reddy's Laboratories Limited,under fasting conditions
Official TitleAn Open Label, Randomized, Single Dose, Oral Bioequivalence Study of Isotretinoin Capsules 20 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of ACCUTANE® Capsules 20 mg of Roche Laboratories Inc., Under Fasting Conditions
Principal SponsorDr. Reddy's Laboratories Limited
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
41 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 45 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Healthy males between 18 and 45 years of age inclusive.
Informed of the nature of the study and given written informed consent.
Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 125 lbs. (Appendix I).
7 exclusion criteria prevent from participating
Hypersensitivity to isotretinoin or related compounds.
Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
Recent history of mental illness, drug addiction, drug abuse or alcoholism.
Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorACCUTANE 20 mg of Roche Laboratories Inc
Group II
ExperimentalIsotretinoin Capsules, 20 mg of Dr.Reddy's Laboratories Ltd
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center