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Quinapril

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 Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

Quinapril · 2 trials · 1 indication

Phase 1 2
NCT00649103Fasting Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mgHealthy
COMPLETED60 Analytics
NCT00649649Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mgHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Fasting Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 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
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 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 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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Frequently asked questions about Quinapril

What is Quinapril used for?

Quinapril is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with completed trials evaluating its pharmacokinetics under fasting and fed conditions. The drug is being developed by Viatris Inc. and is not yet approved for any indication.

Who makes Quinapril?

Quinapril is being developed by Viatris Inc., a company traded on the NASDAQ under the ticker VTRS. The drug is currently in Phase 1 clinical development, with two completed trials in healthy volunteers. Viatris is responsible for the ongoing research and potential commercialization of this investigational product.

What phase is Quinapril in?

Quinapril is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers in the United States. The drug remains investigational and has not received FDA approval. Further clinical studies would be needed to advance it to later stages of development.

What clinical trials is Quinapril in?

Quinapril has two completed Phase 1 clinical trials. NCT00649103 is a fasting study comparing Quinapril Hydrochloride Tablets 40 mg to Accupril Tablets 40 mg, enrolling 60 participants. NCT00649649 is a food study with the same comparison, enrolling 24 participants. Both trials were conducted in the United States with healthy volunteers aged 18 years and older.

Is Quinapril the same as Accupril?

Quinapril is being studied as a generic version of Accupril, which is the brand-name reference drug. The clinical trials compare Quinapril Hydrochloride Tablets 40 mg to Accupril Tablets 40 mg to assess bioequivalence. Quinapril is an investigational product, while Accupril is the established brand-name medication.