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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
March 30, 2008
November 23, 2009
May 2005
May 2005   (Final data collection date for primary outcome measure)
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 ]
Bioequivalence [ Time Frame: within 30 days ]
Complete list of historical versions of study NCT00649870 on ClinicalTrials.gov Archive Site
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Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
Single-Dose Food 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 administration under fed conditions.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy
  • Drug: Valacyclovir Hydrochloride Tablets 1000 mg
    1000mg, single dose fed
  • Drug: Valtrex® Tablets 1000 mg
    1000mg, single dose fed
  • Experimental: 1
    Valacyclovir Hydrochloride Tablets 1000 mg
    Intervention: Drug: Valacyclovir Hydrochloride Tablets 1000 mg
  • Active Comparator: 2
    Valtrex® Tablets 1000 mg
    Intervention: Drug: Valtrex® Tablets 1000 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
June 2005
May 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00649870
VALA-0405
Not Provided
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Wayne Talton, Mylan Inc.
Mylan Pharmaceuticals
Not Provided
Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
Mylan Pharmaceuticals
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP