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Benazepril

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

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

Clinical trial landscape

Benazepril · 2 trials · 1 indication

Phase 1 2
NCT00836537Benazepril HCl 40 mg Tablets, FedHealthy
COMPLETED40 Analytics
NCT00836576Benazepril HCl 40 mg Tablets, FastingHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
Benazepril HCl 40 mg Tablets, Fed
HealthyUnlock trial analytics
PHASE1COMPLETED
Benazepril HCl 40 mg Tablets, Fasting
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax for Benazepril
Blood samples collected over 96 hour period
Bioequivalence based on AUC0-inf for Benazepril
Blood samples collected over 96 hour period
Bioequivalence based on AUC0-t
Blood samples collected over 96 hour period
Bioequivalence based on AUC0-t for Benazepril
Blood samples collected over 96 hour period

Secondary Endpoints

Cmax results for Benazeprilat
Blood samples collected over 96 hour period
AUC0-inf results for Benazeprilat
Blood samples collected over 96 hour period
AUC0-t results for Benazeprilat
Blood samples collected over 96 hour period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Benazepril HCl 40 mg TabletsDRUG1 x 40 mg, single-dose fed
Lotensin® 40 mg TabletsDRUG1 x 40 mg, single-dose fed
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Eligibility Criteria

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

Inclusion Criteria: * Screening Demographics: All volunteers for selected for this study will be healthy men or women 19 years of age or older at the time of dosing. The weight range will not exceed ±20% for height and body frame as per Desirable Weights for Men - 1983 Metropolitan height and Weigh...

Countries:United States
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Frequently asked questions about Benazepril

What is Benazepril used for?

Benazepril is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with trials evaluating the drug in healthy adult participants. The specific medical condition it is intended to treat has not been established, as the current studies focus on healthy individuals.

Who makes Benazepril?

Benazepril is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug's effects in healthy volunteers.

What phase is Benazepril in?

Benazepril is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacokinetics in healthy participants.

What clinical trials is Benazepril in?

Benazepril has two completed Phase 1 clinical trials: NCT00836537, which evaluated the drug under fed conditions, and NCT00836576, which evaluated it under fasting conditions. Both trials enrolled 40 healthy adults each in the United States, with a total enrollment of 80 participants.

Is Benazepril the same as benazepril hydrochloride?

Benazepril is the active ingredient in the drug product benazepril hydrochloride. The clinical trials for this asset are titled "Benazepril HCl 40 mg Tablets," indicating that the drug is formulated as the hydrochloride salt of benazepril.