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

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ClinicalTrials.gov Identifier: NCT00882882
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : March 29, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.

Condition or disease Intervention/treatment Phase
Type II Diabetes Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions
Study Start Date : June 2001
Actual Primary Completion Date : June 2001
Actual Study Completion Date : June 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Experimental: 2
Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
Active Comparator: 3
GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb
Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb
Active Comparator: 4
GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb
Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 23 days ]


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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882882


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: So Ran Hong, M.D. Novum Independent Institutional Review Board

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00882882     History of Changes
Other Study ID Numbers: B013701
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: April 2009

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs