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Lisinopril under fed conditions

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 Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Lisinopril under fed conditions · 1 trial · 1 indication

Phase 1 1
NCT00883506To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and FedHypertension
COMPLETED24 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed
HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
50 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLisinopril 40 mg Tablet under fed conditions.
2ACTIVE_COMPARATORLisinopril 40 mg Tablet (Zestril)
3EXPERIMENTALLisinopril 40 mg Tablet under fasting conditions.

Interventions

NameTypeDescription
Lisinopril 40 mg Tablet (Zestril) under fed conditions.DRUG -
Lisinopril 40 mg Tablet under fasting conditions.DRUG -
Lisinopril 40 mg Tablet under fed conditions.DRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
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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