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Verapamil

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 Trials4
Total Enrollment144

FDA Designations

No designations recorded

Clinical trial landscape

Verapamil · 4 trials · 1 indication

Phase 1 4
NCT00648050Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg to Verelan® PM Extended-Release Capsules 300 mgHealthy
COMPLETED72 Analytics
NCT00647673Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mgHealthy
COMPLETED24 Analytics
NCT00648401Food Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mgHealthy
COMPLETED24 Analytics
NCT00649805Fasting Applesauce Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mgHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg to Verelan® PM Extended-Release Capsules 300 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Applesauce Study of Verapamil HCl Extended-Release Capsules 300 mg and Verelan® PM Extended-Release Capsules 300 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
1EXPERIMENTALVerapamil Hydrochloride Extended-Release Capsules, 300 mg
2ACTIVE_COMPARATORVerelan® PM Extended-Release Capsules, 300 mg

Interventions

NameTypeDescription
Verapamil Hydrochloride Extended-Release Capsules, 300 mgDRUG300mg, single dose fasting
Verelan® PM Extended-Release Capsules, 300 mgDRUG300mg, single dose fasting
Verapamil HCL Extended-Release Capsules 300 mgDRUG300mg, single dose fasting
Verelan® PM Extended-Release Capsules 300 mgDRUG300mg, 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 a negative serum (β HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administrat...

Countries:United States
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