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Benazepril and Hydrochlorothiazide

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Benazepril and Hydrochlorothiazide target and mechanism

Molecular targetACE
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL838

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment80

FDA Designations

No designations recorded

Benazepril and Hydrochlorothiazide clinical trials

Benazepril and Hydrochlorothiazide · 2 trials · 1 indication

Phase 1 2
NCT00649038Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mgHealthy
COMPLETED24 Analytics
NCT00649597Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mgHealthy
COMPLETED56 Analytics
PHASE1COMPLETED
Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBenazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
2ACTIVE_COMPARATORLotensin HCT® Tablets 20 mg/25 mg

Interventions

NameTypeDescription
Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mgDRUG20/25mg, single dose fed
Lotensin HCT® Tablets 20 mg/25 mgDRUG20/25mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 1\. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum -human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening...

Countries:United States
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Frequently asked questions about Benazepril and Hydrochlorothiazide

What is benazepril and hydrochlorothiazide?

Benazepril and hydrochlorothiazide is a fixed-dose combination product containing benazepril hydrochloride and hydrochlorothiazide. It is developed by Viatris Inc. (ticker VTRS) and is also known as Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg. The combination pairs an ACE inhibitor with a thiazide diuretic in a single oral tablet.

What does benazepril and hydrochlorothiazide target?

Benazepril and hydrochlorothiazide contains benazepril, which targets angiotensin-converting enzyme (ACE) as an ACE inhibitor. Hydrochlorothiazide is a thiazide-type diuretic. The benazepril component acts through ACE inhibition, while the hydrochlorothiazide component works through a separate diuretic mechanism. The product is a small molecule combination.

Who makes benazepril and hydrochlorothiazide?

Benazepril and hydrochlorothiazide is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor associated with the clinical studies of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg.

What phase is benazepril and hydrochlorothiazide in?

Benazepril and hydrochlorothiazide is in Phase 1 clinical development. The two registered studies of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg are both Phase 1 trials, and both are completed. No active trials are ongoing.

What clinical trials is benazepril and hydrochlorothiazide in?

Two completed Phase 1 trials have studied benazepril and hydrochlorothiazide: NCT00649597, a fasting study comparing Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg with Lotensin HCT Tablets 20 mg/25 mg in 56 healthy volunteers, and NCT00649038, a fed study of the same comparison in 24 healthy volunteers. Both were conducted in the United States.