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Eplerenone Sandoz Inc., USA

Phase 1

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

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 used for?

Eplerenone Sandoz Inc., USA is a small molecule being developed for hypertension, a cardiovascular condition. It is currently in Phase 1 clinical development as an investigational drug. Two Phase 1 trials have been completed, each enrolling 60 healthy volunteers to study the bioavailability of the 50 mg tablet formulation.

Who makes Eplerenone Sandoz Inc., USA?

Eplerenone Sandoz Inc., USA is being developed by Novartis AG, which trades under the ticker NVS. The drug is a small molecule intended for the treatment of hypertension. It is currently in Phase 1 clinical development, with two completed bioavailability studies.

What phase is Eplerenone Sandoz Inc., USA in?

Eplerenone Sandoz Inc., USA is in Phase 1 clinical development. Two Phase 1 trials have been completed, both focusing on the comparative bioavailability of the 50 mg tablet under fasting and fed conditions. The drug is investigational and has not been approved for hypertension.

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

Eplerenone Sandoz Inc., USA has two completed Phase 1 trials: NCT00865176, a comparative bioavailability study under fasting conditions, and NCT00865618, a comparative bioavailability study under fed conditions. Each trial enrolled 60 healthy volunteers aged 18 years and older, with a total enrollment of 120 participants.

Is Eplerenone Sandoz Inc., USA the same as Eplerenone?

Eplerenone Sandoz Inc., USA is a specific formulation of eplerenone, a small molecule being developed for hypertension. The name includes the developer and country, indicating it is a version of eplerenone. It is currently in Phase 1 clinical development, with two completed bioavailability studies.