NCT00775580

Bioequivalence Study of Atenolol 100mg Tablets Under Fasting Conditions

Single Dose Two-Way Crossover Fasted Bioequivalence Study of Atenolol 100 mg Capsules in Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (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 atenolol 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 atenolol comparing atenolol 100mg tablets of Ranbaxy with Tenormin 100mg capsules in healthy, adult, human, subjects under fasting conditions. A total of 36 non-smoking subjects (26 men and 10 women) were included in this study, of which 35 finished the study according to the protocol,

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Atenolol 100mg Tablets

Timeline

• Start date: 2005-05-01
• Primary completion: 2005-05-01
• Completion: 2005-07-01
• First posted: 2008-10-20
• Last updated: 2008-10-20

Locations

1 site across 1 country: United States