NCT00834444

Famciclovir 500 mg Tablets Under Non-Fasting Conditions

A Single Dose, Comparative Bioavailability Study of Two Formulations of Famciclovir 500 mg Tablets Under Non-Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects 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	Famciclovir 500 mg Tablets	1 x 500 mg, single-dose fasting
DRUG	Famvir® 500 mg Tablets	1 x 500 mg, single-dose fasting

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2009-02-03
• Last updated: 2024-08-20
• Results posted: 2009-08-04

Locations

2 sites across 2 countries: United States, Canada