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Accuretic

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 Enrollment104

FDA Designations

No designations recorded

Clinical trial landscape

Accuretic · 2 trials · 1 indication

Phase 1 2
NCT00648011Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mgHealthy
COMPLETED44 Analytics
NCT00649441Fasting Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mgHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Food Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ Tablets 20 mg/25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Accuretic™ 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
1EXPERIMENTALQuinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
2ACTIVE_COMPARATORAccuretic™ Tablets 20 mg/25 mg

Interventions

NameTypeDescription
Quinapril HCl and Hydrochlorothiazide Tablets 20 mg/25 mgDRUG20/25mg, single dose fed
Accuretic™ 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 beta-human chorionic gonadotropin (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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Frequently asked questions about Accuretic

What is Accuretic used for?

Accuretic is a combination tablet containing quinapril hydrochloride and hydrochlorothiazide, used in healthy volunteers in clinical studies. It is being developed by Viatris Inc. (VTRS) as a small molecule product. The drug is currently in Phase 1 clinical development, with studies focused on healthy participants.

Who makes Accuretic?

Accuretic is developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting clinical trials to evaluate the product in healthy volunteers. As of the latest data, Accuretic is in Phase 1 development.

What phase is Accuretic in?

Accuretic is in Phase 1 clinical development. It has completed two Phase 1 trials, both involving healthy volunteers. The drug is investigational and not yet approved for marketing. Viatris Inc. (VTRS) is the developer of this small molecule product.

What clinical trials is Accuretic in?

Accuretic has completed two Phase 1 clinical trials. NCT00648011 is a food study comparing quinapril HCl and hydrochlorothiazide tablets 20 mg/25 mg to Accuretic tablets 20 mg/25 mg, enrolling 44 participants. NCT00649441 is a fasting study with the same comparison, enrolling 60 participants. Both were conducted in the United States.

Is Accuretic the same as quinapril and hydrochlorothiazide?

Accuretic is a combination tablet containing quinapril hydrochloride and hydrochlorothiazide. Clinical trials have compared the fixed-dose combination to separate tablets of the two active ingredients. The studies were designed to assess bioequivalence under fed and fasting conditions in healthy volunteers.