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Lopressor HCT 100/

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 24, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00649233Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mgPHASE1 COMPLETED 32Jan 1, 2003Feb 1, 2003Apr 24, 20241 United States
NCT00649688Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mgPHASE1 COMPLETED 32Jan 1, 2003Feb 1, 2003Apr 24, 20241 United States
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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
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
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Eligibility Criteria
Age Range18 Years — 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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