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

Tracking Information

First Received Date ^ICMJE

March 30, 2008

Last Updated Date

November 23, 2009

Start Date ^ICMJE

May 2005

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Bioequivalence [ Time Frame: within 30 days ] [ Designated as safety issue: No ]

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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

June 2005

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

Gender

Both

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

Plan to Share Data

Not Provided

IPD Description

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.

Information Provided By

Mylan Pharmaceuticals

Verification Date

November 2009

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

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