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Benazepril and Hydrochlorothiazide

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

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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