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Midodrine

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 Enrollment97
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648440Food Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mgPHASE1 COMPLETED 36Oct 1, 2002Nov 1, 2002Apr 24, 20241 United States
NCT00650364Fasting Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mgPHASE1 COMPLETED 38Aug 1, 2002Sep 1, 2002Apr 24, 20241 United States
NCT00650013Fed Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mgPHASE1 COMPLETED 23Jul 1, 2002Aug 1, 2002Apr 23, 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
1EXPERIMENTALMidodrine HCl Tablets 5 mg
2ACTIVE_COMPARATORProAmatine® Tablets 5 mg
Interventions
NameTypeDescription
Midodrine HCl Tablets 5 mgDRUG5mg, single dose fed
ProAmatine® Tablets 5 mgDRUG5mg, 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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