To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions

Overview[ - collapse ][ - ]

Purpose To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.
ConditionType II Diabetes
InterventionDrug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb
Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb
PhasePhase 1
SponsorSandoz Inc.
Responsible PartySandoz
ClinicalTrials.gov IdentifierNCT00882882
First ReceivedApril 16, 2009
Last UpdatedApril 16, 2009
Last verifiedApril 2009

Tracking Information[ + expand ][ + ]

First Received DateApril 16, 2009
Last Updated DateApril 16, 2009
Start DateJune 2001
Estimated Primary Completion DateJune 2001
Current Primary Outcome MeasuresBioequivalence based on AUC and Cmax [Time Frame: 23 days] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleTo Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions
Official TitleA Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions
Brief Summary
To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting
conditions.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionType II Diabetes
InterventionDrug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb
Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb
Study Arm (s)
  • Experimental: 1
    Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
  • Experimental: 2
    Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
  • Active Comparator: 3
    GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb
  • Active Comparator: 4
    GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment16
Estimated Completion DateJune 2001
Estimated Primary Completion DateJune 2001
Eligibility Criteria
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.
GenderBoth
Ages19 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT00882882
Other Study ID NumbersB013701
Has Data Monitoring CommitteeNot Provided
Information Provided BySandoz
Study SponsorSandoz Inc.
CollaboratorsNot Provided
Investigators Principal Investigator: So Ran Hong, M.D. Novum Independent Institutional Review Board
Verification DateApril 2009