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Valacyclovir

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jun 14, 2010

Valacyclovir development status

FDA approval on record Jun 25, 2001 as Valtrex
Approval holderGlaxosmithkline
ApplicationNDA020550
Highest phase Phase 4 run by GlaxoSmithKline (NCT00306293)
Phase scored for RDYPhase 1
Registered trials 23 across 12 sponsors since Mar 2002

Valacyclovir target and mechanism

ModalitySmall molecule

Also known as Valacyclovir Hydrochloride, Valtrex (R)(Valacyclovir Hydrochloride) CAPLETS 1 gm

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment75

FDA Designations

No designations recorded

Valacyclovir clinical trials

Valacyclovir · 2 trials · 1 indication

Phase 1 2
NCT01136525Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting ConditionsHealthy
COMPLETED41 Analytics
NCT01136538Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed ConditionHealthy
COMPLETED34 Analytics
PHASE1COMPLETED
Bioavailability Study of Valacyclovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fasting Conditions
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Valacycovir HCl Tablets, 1000 mg of Dr. Reddy's Under Fed Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Valacyclovir HydrochlorideEXPERIMENTALValacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
Valtrex (R)ACTIVE_COMPARATORValtrex (R) (Valacyclovir Hydrochloride) CAPLETS 1 gram of GlaxoSmithkline

Interventions

NameTypeDescription
Valacyclovir HydrochlorideDRUGValacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:India
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Frequently asked questions about Valacyclovir

What is Valacyclovir?

Valacyclovir is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It has been studied in Phase 1 clinical trials involving healthy adult volunteers. The specific medical conditions it is intended to treat have not been disclosed in the available development information.

Who makes Valacyclovir?

Valacyclovir is made by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed under the ticker RDY. The company conducted two Phase 1 bioavailability studies of Valacyclovir HCl tablets at a 1000 mg dose, both of which have been completed.

What phase is Valacyclovir in?

Valacyclovir is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The studies were conducted in India and enrolled a total of 75 healthy adult volunteers.

What clinical trials is Valacyclovir in?

Valacyclovir has been evaluated in two completed Phase 1 trials: NCT01136538, a bioavailability study under fed conditions with 34 participants, and NCT01136525, a bioavailability study under fasting conditions with 41 participants. Both trials were active-controlled, randomized, and conducted in India.

Is Valacyclovir the same as Valacyclovir Hydrochloride?

Yes, Valacyclovir Hydrochloride is an alternative name for Valacyclovir. The clinical trials conducted by Dr. Reddy's Laboratories Ltd used Valacyclovir HCl tablets at a 1000 mg dose, referring to the same active ingredient.