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Benazepril

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00836537Benazepril HCl 40 mg Tablets, FedPHASE1 COMPLETED 40Mar 1, 2001Mar 1, 2001May 12, 20231 United States
NCT00836576Benazepril HCl 40 mg Tablets, FastingPHASE1 COMPLETED 40Feb 1, 2001Mar 1, 2001Aug 19, 20241 United States
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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 — 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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