Overview

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

Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mylan Pharmaceuticals
Treatments:
Acyclovir
Valacyclovir
Criteria
Inclusion Criteria:

- healthy, adult subjects, 18 years and older

- able to swallow medication

Exclusion Criteria:

- institutionalized subjects

- history of any significant disease

- use of any prescription or OTC medications within 14 days of start of study

- received any investigational products within 30 days prior to start of study