Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Valacyclovir · 2 trials · 1 indication
| 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...
Valacyclovir is an antiviral small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development by Dr. Reddy's Laboratories Ltd. The ongoing studies are bioavailability trials, which assess how the drug is absorbed and processed in the body under fasting and fed conditions.
Valacyclovir is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 clinical trials for this drug in healthy volunteers.
Valacyclovir is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The current Phase 1 trials are bioavailability studies conducted in healthy volunteers to evaluate how the drug behaves in the body.
Valacyclovir has two completed Phase 1 clinical trials. The first, NCT01136525, is a bioavailability study of Valacyclovir HCl Tablets, 1000 mg under fasting conditions with 41 participants. The second, NCT01136538, is a bioavailability study under fed conditions with 34 participants. Both trials were conducted in India.
Valacyclovir HCl is the hydrochloride salt form of Valacyclovir. The clinical trials for Valacyclovir conducted by Dr. Reddy's Laboratories use Valacyclovir HCl Tablets, 1000 mg, indicating that the drug is administered in this salt form.