Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00882882
First received: April 16, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 23 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2001
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 49 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882882

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

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00882882     History of Changes
Other Study ID Numbers: B013701
Study First Received: April 16, 2009
Last Updated: April 16, 2009
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013