Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Valtrex
Valacyclovir · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-inf
Bioequivalence based on Cmax
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-inf
| Arm | Type | Description |
|---|---|---|
| Valacyclovir | EXPERIMENTAL | Test 1000 mg Valacyclovir Tablet |
| Valtrex | ACTIVE_COMPARATOR | Reference Listed 1000 mg Valtrex Tablet |
| Name | Type | Description |
|---|---|---|
| Valacyclovir | DRUG | 1000 mg Tablet |
Inclusion Criteria * Male or female, non-smokers, 18 years of age and older. * Capable of consent * BMI greater than or equal to 19.0 and less than or equal to 30.0 kg/m2 Exclusion Criteria Subjects to whom any of the following applies will be excluded from the study: * Clinically significant il...
Valacyclovir is a small molecule drug developed by Teva Pharmaceutical Industries Limited. It has been studied in Phase 1 clinical trials involving healthy adult volunteers. The trials were conducted under both fasting and fed conditions to evaluate the 1000 mg tablet formulation.
Valacyclovir is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the Phase 1 clinical trials of the 1000 mg tablet formulation conducted in the United States and Canada.
Valacyclovir is in Phase 1 clinical development. Two Phase 1 trials have been completed, with no active trials currently ongoing. Both studies enrolled healthy adult volunteers and evaluated the 1000 mg tablet under fasting and fed conditions.
Valacyclovir has been evaluated in two completed Phase 1 trials. NCT01149499 studied the 1000 mg tablet under fasting conditions in 60 healthy volunteers in the United States. NCT01149460 studied the 1000 mg tablet under fed conditions in 36 healthy volunteers in Canada.
The two completed Phase 1 trials of Valacyclovir enrolled a total of 96 participants. NCT01149499 enrolled 60 healthy volunteers, and NCT01149460 enrolled 36 healthy volunteers. Both trials were randomized, active controlled, and included adults aged 18 years and older.