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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00865033
First Posted: March 19, 2009
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence according to US FDA guidelines [ Time Frame: 9 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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): NCT00865033


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00865033     History of Changes
Other Study ID Numbers: B053709
First Submitted: March 15, 2009
First Posted: March 19, 2009
Last Update Posted: March 29, 2017
Last Verified: March 2009

Additional relevant MeSH terms:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs