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Lotensin HCT

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 Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Lotensin HCT · 2 trials · 1 indication

Phase 1 2
NCT00649038Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mgHealthy
COMPLETED24 Analytics
NCT00649597Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mgHealthy
COMPLETED56 Analytics
PHASE1COMPLETED
Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® 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
1EXPERIMENTALBenazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg
2ACTIVE_COMPARATORLotensin HCT® Tablets 20 mg/25 mg

Interventions

NameTypeDescription
Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mgDRUG20/25mg, single dose fed
Lotensin HCT® 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 -human chorionic gonadotropin (β-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 Lotensin HCT

What is Lotensin HCT used for?

Lotensin HCT is a combination of benazepril hydrochloride and hydrochlorothiazide, studied in healthy volunteers. It is being developed by Viatris Inc. (VTRS) and is currently in Phase 1 clinical development. The drug is a small molecule and has been evaluated in two completed trials.

Who makes Lotensin HCT?

Lotensin HCT is developed by Viatris Inc., which trades under the ticker VTRS. The company has conducted clinical trials to evaluate the drug in healthy volunteers. As of now, Lotensin HCT is in Phase 1 development, with two completed studies.

What phase is Lotensin HCT in?

Lotensin HCT is in Phase 1 clinical development. It has completed two Phase 1 trials, both involving healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. Viatris Inc. (VTRS) is the developer of this small molecule.

What clinical trials is Lotensin HCT in?

Lotensin HCT has been studied in two completed Phase 1 trials: NCT00649038, a fed study comparing benazepril HCl and hydrochlorothiazide tablets 20 mg/25 mg to Lotensin HCT tablets, and NCT00649597, a fasting study with the same comparison. Both trials enrolled healthy adults in the United States.

Is Lotensin HCT the same as benazepril and hydrochlorothiazide?

Lotensin HCT is a combination product containing benazepril hydrochloride and hydrochlorothiazide. Clinical trials have compared generic benazepril HCl and hydrochlorothiazide tablets to Lotensin HCT tablets to assess bioequivalence. The drug is being developed by Viatris Inc. (VTRS) and is in Phase 1.