MedTrace Logo

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

NCT00650494 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-04-23

No results posted yet for this study

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

DRUG

Valacyclovir Hydrochloride Tablets 1000mg

1000mg, single dose fed

DRUG

Valtrex® 1000 mg

1000mg, single dose fed

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Dorian Williams, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2005-08-31
Completion
2005-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00650494 on ClinicalTrials.gov