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Olmesartan Medoxomil

Phase 1

Healthy | Small molecule | Other |Viatris Inc.|Last Updated: Apr 23, 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_CONTROLLED
Total Trials2
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648219Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mgPHASE1 COMPLETED 36 — — Dec 1, 2005Jan 1, 2006Apr 23, 20241 United States
NCT00649623Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mgPHASE1 COMPLETED 36 — — Dec 1, 2005Dec 1, 2005Apr 23, 20241 United States
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Study Endpoints
Primary Endpoints
The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
blood collections through 48 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALOlmesartan Medoxomil Tablets 40 mg
2ACTIVE_COMPARATORBenicar® Tablets 40 mg
Interventions
NameTypeDescription
Olmesartan Medoxomil Tablets 40 mgDRUG40mg, single dose fed
Benicar® Tablets 40 mgDRUG40mg, single dose fed
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...

Countries:United States
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