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Metoprolol

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 Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

Metoprolol · 4 trials · 1 indication

Phase 1 4
NCT00649233Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mgHealthy
COMPLETED32 Analytics
NCT00649688Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mgHealthy
COMPLETED32 Analytics
NCT00648271Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mgHealthy
COMPLETED19 Analytics
NCT00649116Fed Study of Metoprolol Tartrate Tablets 100 mg and Lopressor® 100 mgHealthy
COMPLETED20 Analytics
PHASE1COMPLETED
Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Metoprolol Tartrate Tablets 25 mg and Lopressor® 50 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Metoprolol Tartrate Tablets 100 mg and Lopressor® 100 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
1EXPERIMENTALMetoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg
2ACTIVE_COMPARATORLopressor HCT® Tablets 100/50 mg

Interventions

NameTypeDescription
Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mgDRUG100/50mg, single dose fed
Lopressor HCT® Tablets 100/50 mgDRUG100/50mg, single dose fed
Metoprolol Tartrate Tablets 25 mgDRUG2x50mg, single dose fed
Lopressor® Tablets 50 mgDRUG1x50mg, single dose fed
Metoprolol Tartrate Tablets 100 mgDRUG100mg, single dose fed
Lopressor® Tablets 100 mgDRUG100mg, 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 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 the evening prior ...

Countries:United States
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