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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01136525 | Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions | PHASE1 | COMPLETED | 41 | — | — | Feb 1, 2007 | May 1, 2007 | Jun 14, 2010 | 1 | India |
| NCT01136538 | Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition | PHASE1 | COMPLETED | 34 | — | — | Feb 1, 2007 | May 1, 2007 | Jun 14, 2010 | 1 | India |
| Arm | Type | Description |
|---|---|---|
| Valacyclovir Hydrochloride | EXPERIMENTAL | Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited |
| Valtrex (R) | ACTIVE_COMPARATOR | Valtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline |
| Name | Type | Description |
|---|---|---|
| Valacyclovir Hydrochloride | DRUG | Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: The subjects were selected for study participation, based on the following criteria: 1. Human subjects aged between 18 and 45 years (including both). 2. Subjects' weight within the normal range according to normal values for the Body Mass Index (18.5 to 24.9 kg/m2) with minimum...