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Eplerenone Sandoz Inc., USA

Phase 1

Hypertension | Small molecule | Cardiovascular |Novartis AG|Last Updated: Mar 29, 2017

Target and mechanism

Molecular targetNR3C2
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Eplerenone Sandoz Inc., USA · 2 trials · 1 indication

Phase 1 2
NCT00865176Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting ConditionsHypertension
COMPLETED60 Analytics
NCT00865618Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed ConditionsHypertension
COMPLETED60 Analytics
PHASE1COMPLETED
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fasting Conditions
HypertensionUnlock trial analytics
PHASE1COMPLETED
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence according to US FDA guidelines
10 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEplerenone 50mg Tablets
2ACTIVE_COMPARATORINSPRA 50mg Tablets

Interventions

NameTypeDescription
Eplerenone 50 mg Tablets Sandoz Inc., USADRUG -
Inspra 50 mg Tablets GD Searle LLC, USADRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Frequently asked questions about Eplerenone Sandoz Inc., USA

What is Eplerenone Sandoz Inc., USA?

Eplerenone Sandoz Inc., USA is a small molecule drug developed by Novartis AG (ticker NVS) for hypertension, a cardiovascular condition. It is also known as Eplerenone 50 mg Tablets Sandoz Inc., USA. The product is in Phase 1 development, with two completed Phase 1 bioavailability trials in healthy adult volunteers.

What is Eplerenone Sandoz Inc., USA used for?

Eplerenone Sandoz Inc., USA is being developed for hypertension, a cardiovascular condition. The clinical program consists of two completed Phase 1 comparative bioavailability studies conducted in healthy adult volunteers under fed and fasting conditions, with a combined enrollment of 120 participants.

What does Eplerenone Sandoz Inc., USA target?

Eplerenone Sandoz Inc., USA targets NR3C2, also known as the mineralocorticoid receptor. It acts as an antagonist at this receptor. By blocking NR3C2, the drug opposes mineralocorticoid receptor signaling, which is the mechanism underlying its development for hypertension.

Who makes Eplerenone Sandoz Inc., USA?

Eplerenone Sandoz Inc., USA is developed by Novartis AG, which trades under the ticker NVS. The drug is a small molecule product candidate being studied for hypertension within the cardiovascular therapeutic area.

What phase is Eplerenone Sandoz Inc., USA in?

Eplerenone Sandoz Inc., USA is in Phase 1 development. Both of its clinical trials are Phase 1 comparative bioavailability studies, and both are completed. No active trials are ongoing. The program enrolled 120 participants in total, and the studies were randomized and active controlled.

What clinical trials is Eplerenone Sandoz Inc., USA in?

Eplerenone Sandoz Inc., USA has been studied in two completed Phase 1 trials: NCT00865618, a comparative bioavailability study of the 50 mg tablets under fed conditions, and NCT00865176, the same comparison under fasting conditions. Each trial enrolled 60 healthy adult volunteers of any sex, aged 18 years and older.