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Lisinopril under fed conditions

Phase 1

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

Lisinopril under fed conditions target and mechanism

Molecular targetACE
Target classInhibitor
ModalitySmall molecule

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

Lisinopril under fed conditions clinical trials

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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Frequently asked questions about Lisinopril under fed conditions

What is lisinopril under fed conditions?

Lisinopril under fed conditions refers to a 40 mg lisinopril tablet (Zestril) administered after food, studied to assess how a meal affects the drug's absorption. Lisinopril is an ACE inhibitor used to treat hypertension. The fed-state designation describes the dosing condition used in a bioequivalence study, not a separate medicine.

What does lisinopril target?

Lisinopril targets angiotensin-converting enzyme, or ACE, and acts as an ACE inhibitor. By inhibiting ACE, lisinopril reduces the conversion of angiotensin I to angiotensin II, which lowers blood pressure. This mechanism underlies its use in hypertension.

Who makes lisinopril under fed conditions?

Novartis AG, which trades under the ticker NVS, is the developer associated with this lisinopril 40 mg tablet (Zestril) formulation studied under fed conditions. Lisinopril itself is a widely available generic ACE inhibitor, and this listing refers to the Novartis-associated product evaluated in the referenced trial.

What phase is lisinopril under fed conditions in?

Lisinopril under fed conditions was evaluated in a Phase 1 trial. The study is completed, and no active trials are ongoing for this specific fed-condition assessment. Lisinopril is an established hypertension therapy, and this Phase 1 work addressed bioequivalence rather than initial safety or efficacy testing.

What clinical trial is lisinopril under fed conditions in?

Lisinopril under fed conditions was studied in NCT00883506, titled to demonstrate the relative bioequivalence of lisinopril 1 x 40 mg tablet under fasting and fed conditions. The Phase 1 trial enrolled 24 healthy male volunteers aged 18 years and older, was randomized and active controlled, and is completed.

Is lisinopril under fed conditions the same as Zestril?

Yes, lisinopril under fed conditions refers to the lisinopril 40 mg tablet also known as Zestril, given after food. Zestril is a brand name for lisinopril, an ACE inhibitor used for hypertension. The fed-condition wording describes how the tablet was administered in the bioequivalence study, not a different drug.