NCT00775177

Bioequivalence Study of Doxycycline Monohydrate 100mg Tablets Under Fasting Conditions

Single Dose Two-Way Crossover Fasted Bioequivalence Study of Doxycycline Monohydrate 100 mg Tablets in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate formulations after administration of single doses to normal healthy subjects under fasted 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 Doxycycline monohydrate comparing Doxycycline monohydrate 100mg tablets of Ranbaxy Pharmaceuticals Inc with Adoxa ® 100mg tablets of Bradley Pharmaceuticals, Inc. in healthy, adult, human, subjects under fasting conditions. A total of 32 non-smoking subjects (men and women) were included in this study, of which 31 finished the study according to the protocol,

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Doxycycline monohydrate 100mg tablets	Bioequivalence Doxycycline monohydrate 100mg tablets fasting condition

Timeline

• Start date: 2005-06-01
• Primary completion: 2005-06-01
• Completion: 2005-08-01
• First posted: 2008-10-20
• Last updated: 2008-10-20

Locations

1 site across 1 country: United States