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Valganciclovir

Phase 4

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Nov 21, 2014

Valganciclovir development status

Highest phase Phase 4 run by Hoffmann-La Roche (NCT01663740)
Phase scored for RDYPhase 1
Registered trials 24 across 11 sponsors since Aug 2001

Valganciclovir target and mechanism

ModalitySmall molecule

Also known as Valganciclovir Hydrochloride, Valcyte

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment149

FDA Designations

No designations recorded

Valganciclovir clinical trials

Valganciclovir · 2 trials · 1 indication

Phase 1 2
NCT02296723Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed ConditionHealthy
COMPLETED66 Analytics
NCT02297854Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting ConditionHealthy
COMPLETED83 Analytics
PHASE1COMPLETED
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under curve (AUC)
0.00 and at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.333, 2.667, 3.00, 3.333, 3.667, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Valganciclovir Hydrochloride Tablets 450 mgEXPERIMENTALValganciclovir Hydrochloride Tablets 450 mg of Dr. Reddys Laboratories Limited
ValcyteACTIVE_COMPARATORValcyte® 450 mg tablets of Genentech USA Inc., Sanfrancisco

Interventions

NameTypeDescription
Valganciclovir HydrochlorideDRUGValganciclovir Hydrochloride Tablets 450 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, adult, human volunteers between 18 to 55 years of age (both inclusive) living in and around Ahmedabad city or western part of lndia * Having a Body Mass Index (BMD between 18.5 - 24.9 (both inclusive), calculated as weight in kg / height in meter2 * Not having any sig...

Countries:India
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Frequently asked questions about Valganciclovir

What is Valganciclovir?

Valganciclovir is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is being studied in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed. It is also known as Valganciclovir Hydrochloride.

Who makes Valganciclovir?

Valganciclovir is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed under the ticker RDY. The company is conducting clinical development of the drug, which is currently in Phase 1 testing.

What phase is Valganciclovir in?

Valganciclovir is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for any indication based on the available information.

What clinical trials is Valganciclovir in?

Valganciclovir has been evaluated in two completed Phase 1 bioavailability trials. NCT02297854 studied 450 mg tablets under fasting conditions in 83 healthy volunteers in India. NCT02296723 studied the same tablets under fed conditions in 66 healthy volunteers in India. Both trials are completed.

Is Valganciclovir the same as Valganciclovir Hydrochloride?

Yes, Valganciclovir Hydrochloride is an alternative name for Valganciclovir. The two names refer to the same drug asset developed by Dr. Reddy's Laboratories Ltd. The clinical trials listed for this drug use the name Valganciclovir Hydrochloride.