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Pioglitazone

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 Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

Pioglitazone · 2 trials · 1 indication

Phase 1 2
NCT00649012Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mgHealthy
COMPLETED40 Analytics
NCT00649558Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mgHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mg
Healthy
NCT0064901240
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PHASE1COMPLETED
Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mg
Healthy
NCT0064955836
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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
1EXPERIMENTALPioglitazone HCl Tablets 45 mg
2ACTIVE_COMPARATORActos® Tablets 45 mg

Interventions

NameTypeDescription
Pioglitazone HCl Tablets 45 mgDRUG45mg, single dose fed
Actos® Tablets 45 mgDRUG45mg, 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 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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