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Amlodipine and Benazepril

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

Amlodipine and Benazepril · 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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