Valacyclovir 1000 mg Tablet Under Fasting Conditions
- Registration Number
- NCT01149499
- Lead Sponsor
- Teva Pharmaceuticals USA
- Brief Summary
The objective of this study is to compare the rate and extent of absorption of valacyclovir 1000 mg tablet (test) versus Valtrex (reference), administered as 1 x 1000 mg tablet under fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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 Valacyclovir Tablet Valtrex Valacyclovir Reference Listed 1000 mg Valtrex Tablet
- Primary Outcome Measures
Name Time Method Cmax (maximum observed concentration of drug substance in plasma) Blood samples collected over 16 hour period Bioequivalence based on Cmax
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) Blood samples collected over 16 hour period Bioequivalence based on AUC0-t
AUC0-inf (area under the concentration-time curve from time zero to infinity) Blood samples collected over 16 hour period Bioequivalence based on AUC0-inf
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRACS Institute, Ltd.
🇺🇸East Grand Forks, Minnesota, United States