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Actos

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

Actos · 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
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Pioglitazone HCl Tablets 45 mg and Actos® Tablets 45 mg
HealthyUnlock trial analytics

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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Frequently asked questions about Actos

What is Actos used for?

Actos is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed trials evaluating the drug in healthy individuals. Actos is being developed by Viatris Inc. (NASDAQ: VTRS).

Who makes Actos?

Actos is being developed by Viatris Inc., a global healthcare company traded on NASDAQ under the ticker VTRS. The drug is currently in Phase 1 clinical development, with two completed trials in healthy volunteers.

What phase is Actos in?

Actos is in Phase 1 clinical development. Two Phase 1 trials have been completed, both enrolling healthy volunteers in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Actos in?

Actos has two completed Phase 1 clinical trials: NCT00649012, a food study comparing pioglitazone HCl tablets 45 mg to Actos tablets 45 mg, and NCT00649558, a fasting study with the same comparison. Both trials enrolled healthy adults aged 18 years and older in the United States.

Is Actos the same as pioglitazone?

Actos is a brand name for pioglitazone hydrochloride. The clinical trials for Actos compare pioglitazone HCl tablets to Actos tablets, confirming they are the same drug substance. Actos is being developed by Viatris Inc. (NASDAQ: VTRS).