Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00650494 | Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg | PHASE1 | COMPLETED | 66 | — | — | Aug 1, 2005 | Aug 1, 2005 | Apr 23, 2024 | 1 | United States |
| NCT00649870 | Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg | PHASE1 | COMPLETED | 26 | — | — | May 1, 2005 | Jun 1, 2005 | Apr 23, 2024 | 1 | United States |
| NCT00649974 | Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg | PHASE1 | COMPLETED | 28 | — | — | May 1, 2005 | May 1, 2005 | Apr 23, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Valacyclovir Hydrochloride Tablets 1000mg |
| 2 | ACTIVE_COMPARATOR | Valtrex® Tablets 1000 mg |
| Name | Type | Description |
|---|---|---|
| Valacyclovir Hydrochloride Tablets 1000mg | DRUG | 1000mg, single dose fed |
| Valtrex® 1000 mg | DRUG | 1000mg, single dose fed |
| Valacyclovir Hydrochloride Tablets 1000 mg | DRUG | 1000mg, single dose fed |
| Valtrex® Tablets 1000 mg | DRUG | 1000mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the ev...