NCT00650494

Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg

Single-Dose Food in Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GSK's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Valacyclovir Hydrochloride Tablets 1000mg	1000mg, single dose fed
DRUG	Valtrex® 1000 mg	1000mg, single dose fed

Timeline

• Start date: 2005-08-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2008-04-01
• Last updated: 2024-04-23

Locations

1 site across 1 country: United States