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Lotrel

Phase 1

Healhty | 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 Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

Lotrel · 2 trials · 2 indications

Phase 1 2
NCT00649402Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mgHealhty
COMPLETED64 Analytics
NCT00649519Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mgHealthy
COMPLETED54 Analytics
PHASE1COMPLETED
Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
Healhty
NCT0064940264
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PHASE1COMPLETED
Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg
Healthy
NCT0064951954
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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
1EXPERIMENTALAmlodipine and Benazepril HCl Capsules 10 mg/20 mg
2ACTIVE_COMPARATORLotrel® Capsules 10 mg/20 mg

Interventions

NameTypeDescription
Amlodipine and Benazepril HCl Capsules 10 mg/20 mgDRUG10/120mg, single dose fed
Lotrel® Capsules 10 mg/20 mgDRUG10/20mg, 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 (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the eve...

Countries:United States
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Frequently asked questions about Lotrel

What is Lotrel used for?

Lotrel is a combination of amlodipine and benazepril hydrochloride, used in studies involving healthy volunteers. It is being developed by Viatris Inc. (VTRS) as a small molecule product. The drug is currently in Phase 1 clinical development, with studies conducted in the United States.

Who makes Lotrel?

Lotrel is developed by Viatris Inc., which trades under the ticker VTRS. The company is conducting clinical trials to evaluate the drug in healthy volunteers. As of the latest data, Lotrel is in Phase 1 development with one completed trial.

What phase is Lotrel in?

Lotrel is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and there are no active trials currently ongoing for this product.

What clinical trials is Lotrel in?

Lotrel has been studied in two Phase 1 clinical trials. NCT00649402 is a fed study comparing amlodipine and benazepril HCl capsules 10 mg/20 mg to Lotrel capsules, with 64 participants. NCT00649519 is a fasting study with 54 participants. Both trials were completed in the United States.

Is Lotrel the same as amlodipine and benazepril hydrochloride?

Lotrel is a brand name for a combination product containing amlodipine and benazepril hydrochloride. Clinical trials have been conducted to compare generic versions of amlodipine and benazepril HCl capsules to Lotrel, indicating that Lotrel is the reference product for these studies.