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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