Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
Sponsor
Mylan Pharmaceuticals Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00649870
Collaborator
(none)
26
1
2
1
25.5
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 administration under fed conditions.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
26 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
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 Start Date
:
May 1, 2005
Actual Primary Completion Date
:
May 1, 2005
Actual Study Completion Date
:
Jun 1, 2005
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Valacyclovir Hydrochloride Tablets 1000 mg |
Drug: Valacyclovir Hydrochloride Tablets 1000 mg
1000mg, single dose fed
|
Active Comparator: 2 Valtrex® Tablets 1000 mg |
Drug: Valtrex® Tablets 1000 mg
1000mg, single dose fed
|
Outcome Measures
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. [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.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00649870
Other Study ID Numbers:
- VALA-0405
First Posted:
Apr 1, 2008
Last Update Posted:
Nov 25, 2009
Last Verified:
Nov 1, 2009
Additional relevant MeSH terms: