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

Official Title: “Single-Dose Fasting In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers”

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.

Intervention(s) in this Clinical Trial

• Drug: Valacyclovir Hydrochloride Tablets 1000 mg
  • 1000mg, single dose fasting
• Drug: Valtrex® Tablets 1000 mg
  • 1000mg, single dose fasting

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Valacyclovir Hydrochloride Tablets 1000 mg
• Active Comparator: 2
  • Valtrex® Tablets 1000 mg

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
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Mylan Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Dorian Williams, M.D. Principal Investigator Kendle International Inc.  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00649974

Study ID Number: VALA-0404

ClinicalTrials.gov Identifier: NCT00649974

Health Authority: United States: Institutional Review Board

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