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GLUCOPHAGE Bristol-Myers Squibb

Phase 1

Type II Diabetes | Small molecule | Metabolic |Novartis AG|Last Updated: Mar 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

GLUCOPHAGE Bristol-Myers Squibb · 1 trial · 1 indication

Phase 1 1
NCT00882882To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting ConditionsType II Diabetes
COMPLETED16 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions
Type II DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
23 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMetformin HCL 500 mg Extended-Release Tablets, Geneva PTC
2EXPERIMENTALMetformin HCL 500 mg Extended-Release Tablets, Geneva PTC
3ACTIVE_COMPARATORGLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb
4ACTIVE_COMPARATORGLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb

Interventions

NameTypeDescription
Metformin HCL 500 mg Extended-Release Tablets, Geneva PTCDRUG -
GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers SquibbDRUG -
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Eligibility Criteria

Age Range19 Years to 49 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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Competitive Landscape -Diabetes Complications 6 trials (matched to "Type II Diabetes")