Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg

• Sponsor: Mylan Pharmaceuticals Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00649974
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2

Study Details

Study Description

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 administered under fasting conditions.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Valacyclovir Hydrochloride Tablets 1000 mg; Drug: Valtrex® Tablets 1000 mg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: Single-Dose Fasting In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: May 1, 2005
• Actual Study Completion Date: May 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Valacyclovir Hydrochloride Tablets 1000 mg	Drug: Valacyclovir Hydrochloride Tablets 1000 mg; 1000mg, single dose fasting
Active Comparator: 2 Valtrex® Tablets 1000 mg	Drug: Valtrex® Tablets 1000 mg; 1000mg, single dose fasting

Outcome Measures

Primary Outcome Measures

1. 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. [blood collections through 24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Kendle International Inc.	Morgantown	West Virginia	United States	26505

Sponsors and Collaborators

• Mylan Pharmaceuticals Inc

Investigators

• Principal Investigator: Dorian Williams, M.D., Kendle International Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00649974
• Other Study ID Numbers: VALA-0404
• First Posted: Apr 1, 2008
• Last Update Posted: Nov 25, 2009
• Last Verified: Nov 1, 2009

• Additional relevant MeSH terms: Valacyclovir

Study Results

No Results Posted as of Nov 25, 2009