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Metaglip /

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 Enrollment72
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00648505Food Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mgPHASE1 COMPLETED 36Jun 1, 2005Jun 1, 2005Apr 24, 20241 United States
NCT00649454Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mgPHASE1 COMPLETED 36Jun 1, 2005Jun 1, 2005Apr 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
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTALGlipizide and Metformin HCl Tablets 5 mg/500 mg
2ACTIVE_COMPARATORMetaglip® Tablets 5 mg/500 mg
Interventions
NameTypeDescription
Glipizide and Metformin HCl Tablets 5 mg/500 mgDRUG5/500mg, single dose fed
Metaglip® Tablets 5 mg/500 mgDRUG5/500mg, 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/or non-pregnant, non-lactating female a. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration. I...

Countries:United States
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