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Valacyclovir · 3 trials · 1 indication
| 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...
Valacyclovir is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program is undisclosed. Viatris has conducted three completed Phase 1 trials of Valacyclovir Hydrochloride Tablets 1000 mg, all in healthy adult volunteers in the United States.
Valacyclovir is developed by Viatris Inc., which trades under the ticker VTRS. Viatris sponsored the Phase 1 clinical program evaluating Valacyclovir Hydrochloride Tablets 1000 mg, including the fed and fasting bioavailability studies conducted in the United States.
Valacyclovir is in Phase 1 clinical development. Three Phase 1 trials have been completed, and none are currently active. The program enrolled a total of 120 participants across these completed studies, which were randomized and active controlled, though not double blinded.
Valacyclovir has been evaluated in three completed Phase 1 trials: NCT00650494, a fed study with 66 healthy participants; NCT00649974, a fasting study with 28 healthy participants; and NCT00649870, a food study with 26 healthy participants. All three compared Valacyclovir Hydrochloride Tablets 1000 mg with Valtrex Tablets 1000 mg in the United States.
The Valacyclovir Phase 1 trials used an active control design, comparing Valacyclovir Hydrochloride Tablets 1000 mg against Valtrex Tablets 1000 mg. The studies were randomized but not double blinded, and all enrolled healthy adult volunteers aged 18 years and older in the United States.