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Metaglip

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

Metaglip · 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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Frequently asked questions about Metaglip

What is Metaglip?

Metaglip is a small molecule drug being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. Metaglip is being studied in healthy volunteers, and it is an investigational drug, not yet approved by the FDA.

What is Metaglip used for?

Metaglip is being studied for use in healthy volunteers. The clinical trials for Metaglip are food and fasting studies, which are typically conducted to assess the pharmacokinetics of a drug. The drug is currently in Phase 1 development.

Who makes Metaglip?

Metaglip is being developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of Metaglip.

What phase is Metaglip in?

Metaglip is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA. The drug is being studied in healthy volunteers in two completed Phase 1 trials.

What clinical trials is Metaglip in?

Metaglip has been studied in two completed Phase 1 clinical trials. The first trial, NCT00648505, is a food study comparing Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip Tablets 5 mg/500 mg. The second trial, NCT00649454, is a fasting study with the same comparison. Both trials enrolled 36 healthy volunteers each.