NCT00777413

Bioequivalecne Study of Minocycline 100mg Tablets Under Fed Conditions

Single Dose Two-Way Crossover Fed Bioequivalence Study of Minocycline 100 mg Capsules in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to determine the bioequivalence of Minocycline formulations after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Detailed description

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing minocycline 100mg tablets of Ranbaxy with Minocin 100mg capsules of in healthy, adult, human, subjects under fed conditions. A total of 24 non-smoking subjects (17 men and 7 women) were included in this study, of which 24 finished the study according to the protocol.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Minocycline 100mg Tablets

Timeline

• Start date: 2002-11-01
• Primary completion: 2002-11-01
• Completion: 2003-01-01
• First posted: 2008-10-22
• Last updated: 2008-10-22

Locations

1 site across 1 country: United States