NCT01888289

Bioequivalence Study of Isotretinoin Capsules 40 mg Under Fasting Condition

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 Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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, two-treatment, single dose, oral bioequivalence study of Isotretinoin capsules 40 mg of Dr. Reddy's Laboratories Limited,under fasting conditions

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Isotretinoin	Isotretinoin Capsules,40 mg

Timeline

• Start date: 2001-07-01
• Primary completion: 2001-08-01
• Completion: 2001-09-01
• First posted: 2013-06-27
• Last updated: 2013-06-27

Locations

1 site across 1 country: United States