Valacyclovir 1000 mg Tablet Under Fed Conditions
- Sponsor
- Teva Pharmaceuticals USA
- Study ID
- NCT01149460
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Valacyclovir — DRUGTest 1000 mg Tablet
- Valacyclovir — DRUGReference Listed Valacyclovir 1000 mg Tablet
Study Details
The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed conditions.
Key Dates
- Start date
- Sep 30, 2004
- Status verified
- Aug 2024
- Primary completion
- Sep 30, 2004
- Completion
- Sep 30, 2004
Study Design
- Enrollment
- 36 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Experimental: ValacyclovirTest 1000 mg Tablet
- Active Comparator: ValtrexReference Listed Valacyclovir 1000 mg Tablet
Primary Outcome Measure
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir [ Time Frame: Blood samples collected over 12 hour period ]
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