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Valganciclovir

Phase 1

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

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

Clinical trial landscape

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
Healthy
NCT0229672366
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PHASE1COMPLETED
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
Healthy
NCT0229785483
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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 used for?

Valganciclovir is an investigational small molecule being studied in healthy volunteers. It is being evaluated in bioavailability studies of Valganciclovir Hydrochloride Tablets 450 mg under fed and fasting conditions. The drug is currently in Phase 1 clinical development and is not approved for any indication.

Who makes Valganciclovir?

Valganciclovir is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded on the New York Stock Exchange under the ticker RDY. The company is conducting clinical trials to evaluate the bioavailability of Valganciclovir Hydrochloride Tablets 450 mg in healthy subjects.

What phase is Valganciclovir in?

Valganciclovir is in Phase 1 clinical development. Two Phase 1 bioavailability studies have been completed, with a total of 149 healthy volunteers enrolled. The drug is investigational and has not received FDA approval.

What clinical trials is Valganciclovir in?

Valganciclovir has two completed Phase 1 clinical trials. NCT02296723 is a bioavailability study under fed conditions with 66 participants, and NCT02297854 is a bioavailability study under fasting conditions with 83 participants. Both trials were conducted in India with healthy volunteers aged 18 years and older.

Is Valganciclovir the same as Valganciclovir Hydrochloride?

Valganciclovir is the active ingredient in Valganciclovir Hydrochloride Tablets 450 mg, which is the formulation being studied in clinical trials. The trials evaluate the bioavailability of this tablet form under fed and fasting conditions in healthy volunteers.