DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Valacyclovir Hydrochloride Tablets 1000 mg (Drug); Valtrex® Tablets 1000 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Mylan Pharmaceuticals

Official(s) and/or principal investigator(s):
Dorian Williams, M.D., Principal Investigator, Affiliation: Kendle International Inc.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Kendle International Inc., Morgantown, West Virginia 26505, United States
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

FDA Enforcement Report Index

Medwatch, FDA Safety Information and Adverse Event Reporting Program

Starting date: May 2005
Last updated: November 23, 2009

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017