Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg - Full Text View

Sponsor:	Mylan Pharmaceuticals
Information provided by:	Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00649870

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 I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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:

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

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
1: Experimental Valacyclovir Hydrochloride Tablets 1000 mg	Drug: Valacyclovir Hydrochloride Tablets 1000 mg 1000mg, single dose fed
2: Active Comparator 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:	Mylan Inc. ( Wayne Talton )
Study ID Numbers:	VALA-0405
Study First Received:	March 30, 2008
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00649870 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Valacyclovir
Anti-Infective Agents
Acyclovir

Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010