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Quinapril

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 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 Enrollment84
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00649103Fasting Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mgPHASE1 COMPLETED 60Dec 1, 2002Jan 1, 2003Apr 24, 20241 United States
NCT00649649Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mgPHASE1 COMPLETED 24Dec 1, 2002Jan 1, 2003Apr 24, 20241 United States
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Study Endpoints
Primary Endpoints
Bioequivalence
within 30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALQuinapril Hydrochloride Tablets 40 mg
2ACTIVE_COMPARATORAccupril® Tablets 40 mg
Interventions
NameTypeDescription
Quinapril Hydrochloride Tablets 40 mgDRUG40mg, single dose fasting
Accupril® Tablets 40 mgDRUG40mg, single dose fasting
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Eligibility Criteria
Age Range18 Years — 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 beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to of the study and on the evening prior to e...

Countries:United States
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