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Glipizide and Metformin

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Glipizide and Metformin · 2 trials · 1 indication

Phase 1 2
NCT00648505Food Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mgHealthy
COMPLETED36 Analytics
NCT00649454Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mgHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Food Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg
HealthyUnlock trial analytics

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 to 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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