NCT00835536

Ribavirin 200 mg Tablets Under Non-Fasting Conditions

A Relative Bioavailability Study of Ribavirin 200 mg Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of ribavirin 200 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of COPEGUS™ 200 mg tablets (Roche) in healthy, adult, non-smoking, females (who are unable to become pregnant) under non-fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ribavirin 200 mg tablets	1 x 200 mg, single-dose non-fasting
DRUG	COPEGUS™ 200 mg Tablets	1 x 200 mg, single-dose non-fasting

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2009-02-03
• Last updated: 2024-08-20
• Results posted: 2009-08-18

Locations

2 sites across 1 country: United States