Bioequivalence Study of Isotretinoin Capsules 20 mg Under Fasting Condition

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01888341

Enrollment

Registered

2013-06-27

Start date

2002-08-31

Completion date

2002-08-31

Last updated

2013-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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 fasting conditions

Detailed description

An open label, randomized, single dose, oral bioequivalence study of Isotretinoin capsules 20 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Interventions

DRUGIsotretinoin

Isotretinoin Capsules,20 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy males between 18 and 45 years of age inclusive. 2. Informed of the nature of the study and given written informed consent. 3. 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).

Exclusion criteria

1. Hypersensitivity to isotretinoin or related compounds. 2. Any history of a clinical condition which might affect drug absorption, metabolism or excretion. 3. Recent history of mental illness, drug addiction, drug abuse or alcoholism. 4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. 5. Received an investigational drug within the 4 weeks prior to study dosing. 6. Currently taking any prescription medication within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. 7. Regular tobacco use in the 3 months prior to study dosing.

Design outcomes

Primary

Measure	Time frame
Area under curve (AUC)	Pre-dose (0) and 0.5, 1,1.5,2,2.5,3,4,5,6,8,10,16,24,36,48,72 and 96 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026