Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
Overview
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.
Full Title of Study: “Single-Dose Fasting In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: May 2005
Interventions
- Drug: Valacyclovir Hydrochloride Tablets 1000 mg
- 1000mg, single dose fasting
- Drug: Valtrex® Tablets 1000 mg
- 1000mg, single dose fasting
Arms, Groups and Cohorts
- Experimental: 1
- Valacyclovir Hydrochloride Tablets 1000 mg
- Active Comparator: 2
- Valtrex® Tablets 1000 mg
Clinical Trial Outcome Measures
Primary Measures
- The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
- Time Frame: blood collections through 24 hours
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Mylan Pharmaceuticals Inc
- Provider of Information About this Clinical Study
- Wayne Talton, Mylan Inc.
- Overall Official(s)
- Dorian Williams, M.D., Principal Investigator, Kendle International Inc.
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