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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
History of Changes
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
 Drug: Metformin HCL Tablets, 1000 mg Sandoz
Drug: Glucophage 1000 mg
 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 1000 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence according to US FDA guidelines [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Metformin HCL Tablets, 1000 mg
 Drug: Metformin HCL Tablets, 1000 mg Sandoz
Active Comparator: 2
Glucophage 1000 mg Tablets
 Drug: Glucophage 1000 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
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: NCT00865033

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Soran Hong, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00865033     History of Changes
Other Study ID Numbers: B053709
Study First Received: March 15, 2009
Last Updated: March 18, 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 23, 2013