Valacyclovir 1000 mg Tablet Under Fed Conditions
- Registration Number
- NCT01149460
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Valacyclovir Valacyclovir Test 1000 mg Tablet Valtrex Valacyclovir Reference Listed Valacyclovir 1000 mg Tablet
- Primary Outcome Measures
Name Time Method AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Valacyclovir Blood samples collected over 12 hour period Bioequivalence based on AUC0-inf
Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Valacyclovir Blood samples collected over 12 hour period Bioequivalence based on Cmax
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Valacyclovir Blood samples collected over 12 hour period Bioequivalence based on AUC0-t
- Secondary Outcome Measures
Name Time Method AUC0-t (Area Under Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) - Acyclovir Blood samples collected over 24 hour period Cmax (Maximum Observed Concentration of Drug Substance in Plasma) - Acyclovir Blood samples collected over 24 hour period AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) - Acyclovir Blood samples collected over 24 hour period
Trial Locations
- Locations (1)
Anapharm Inc.
🇨🇦Sainte-Foy, Quebec, Canada