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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, West Virginia | |
| Kendle International Inc. | |
| Morgantown, West Virginia, United States, 26505 | |
| Principal Investigator: | Dorian Williams, M.D. | Kendle International Inc. |
More Information
| 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 |
|
Valacyclovir Anti-Infective Agents Acyclovir |
Therapeutic Uses Antiviral Agents Pharmacologic Actions |