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Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00649870
First received: March 30, 2008
Last updated: November 23, 2009
Last verified: November 2009
History of Changes
  Purpose

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 administration under fed conditions.


Condition Intervention Phase
Healthy
 Drug: Valacyclovir Hydrochloride Tablets 1000 mg
Drug: Valtrex® Tablets 1000 mg
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single-Dose Food In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: May 2005
Study Completion Date: June 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Valacyclovir Hydrochloride Tablets 1000 mg
 Drug: Valacyclovir Hydrochloride Tablets 1000 mg
1000mg, single dose fed
Active Comparator: 2
Valtrex® Tablets 1000 mg
 Drug: Valtrex® Tablets 1000 mg
1000mg, single dose fed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00649870

Locations
United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
  More Information

Additional Information:
Mylan Pharmaceuticals Inc. - Clinical Trial Results  This link exits the ClinicalTrials.gov site
Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use  This link exits the ClinicalTrials.gov site
Recalls, Market Withdrawals and Safety Alerts  This link exits the ClinicalTrials.gov site
FDA Enforcement Report Index  This link exits the ClinicalTrials.gov site
Medwatch, FDA Safety Information and Adverse Event Reporting Program  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT00649870     History of Changes
Other Study ID Numbers: VALA-0405
Study First Received: March 30, 2008
Last Updated: November 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Valacyclovir
Acyclovir
Antiviral Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013