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A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00865033
First received: March 15, 2009
Last updated: March 18, 2009
Last verified: March 2009

March 15, 2009
March 18, 2009
November 2005
November 2005   (final data collection date for primary outcome measure)
Bioequivalence according to US FDA guidelines [ Time Frame: 9 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865033 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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A Relative Bioavailability Study of Metformin HCL Tablets, 1000 mg Under Fasting Conditions
A Relative Bioavailability Study of Metformin HCL 1000 mg Tablets Under Fasting Conditions

The purpose of this study is to demonstrate the relative bioequivalence of Metformin HCL Tablets, 1000 mg under fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Metformin HCL Tablets, 1000 mg Sandoz
  • Drug: Glucophage 1000 mg
  • Experimental: 1
    Metformin HCL Tablets, 1000 mg
    Intervention: Drug: Metformin HCL Tablets, 1000 mg Sandoz
  • Active Comparator: 2
    Glucophage 1000 mg Tablets
    Intervention: Drug: Glucophage 1000 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
November 2005
November 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00865033
B053709
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: Soran Hong, M.D. Novum Pharmaceutical Research Services
Sandoz
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP