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

Tracking Information
First Submitted Date ICMJE	March 30, 2008
First Posted Date ICMJE	April 1, 2008
Last Update Posted Date	November 25, 2009
Study Start Date ICMJE	May 2005
Actual Primary Completion Date	May 2005 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 23, 2009)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: March 31, 2008)	Bioequivalence [ Time Frame: within 30 days ]
Change History	Complete list of historical versions of study NCT00649870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
Official Title ICMJE	Single-Dose Food In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label)
Condition ICMJE	Healthy
Intervention ICMJE	Drug: Valacyclovir Hydrochloride Tablets 1000 mg 1000mg, single dose fed; Drug: Valtrex® Tablets 1000 mg 1000mg, single dose fed
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 31, 2008)	26
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2005
Actual Primary Completion Date	May 2005 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00649870
Other Study ID Numbers ICMJE	VALA-0405
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Wayne Talton, Mylan Inc.
Study Sponsor ICMJE	Mylan Pharmaceuticals
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Dorian Williams, M.D. Kendle International Inc.
PRS Account	Mylan Pharmaceuticals
Verification Date	November 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP