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Metolazone

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 Trials3
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00650195Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mgPHASE1 COMPLETED 56Feb 1, 2004Mar 1, 2004Apr 24, 20241 United States
NCT00649181Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mgPHASE1 COMPLETED 52Oct 1, 2003Nov 1, 2003Apr 24, 20241 United States
NCT00649051Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mgPHASE1 COMPLETED 52Dec 1, 2002Jan 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
1EXPERIMENTALMetolazone Tablets 10 mg
2ACTIVE_COMPARATORZaroloxyn® Tablets 10 mg
Interventions
NameTypeDescription
Metolazone Tablets 10 mgDRUG10mg, single dose fasting
Zaroloxyn® Tablets 10 mgDRUG10mg, single dose fasting
Metolazone Tablets 5 mgDRUG2x5mg, single dose fasting
Zaroloxyn® Tablets 5 mgDRUG2x5mg, single dose fasting
Metolazone Tablets 2.5 mgDRUG4x2.5mg, single dose fasting
Zaroloxyn® Tablets 2.5 mgDRUG4x2.5mg, single dose fasting
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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/or non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum b-human chorionic gonadotropin (β-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening pr...

Countries:United States
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