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Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

This study has been withdrawn prior to enrollment.
(Drug was not sent)
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00648869
First received: March 27, 2008
Last updated: October 25, 2009
Last verified: March 2008
History of Changes
  Purpose

Single-dose, randomized, open-label, cross over study. The study will have an open-label, 3 period, 3 treatments, and randomized design.

Each volunteer will receive a Metformin gum 2x250mg, Metformin gum 1x250mg & Metformin tablet 500mg


Condition Intervention
Healthy
 Drug: metformin tablet, metformin gum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet). [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the effect on blood glucose levels as well as safety and tolerability of one time administration of the Metformin Gum and Metformin tablet. [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: June 2008
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: metformin tablet, metformin gum
    500 mg, 250 mg
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men ranging in age from 18-40
  • Good general health as determined by medical history, physical examination, ECG, Blood pressure, and clinical laboratory tests (hematology & clinical chemistry) obtained within 14 days prior to the start of the study.
  • BMI >18&<30.
  • Willing and able to abide by the dietary requirements of the study.
  • Willing and able to give written informed consent in a manner approved by the Ethics Committee.

Exclusion Criteria:

  • History of known or suspected clinically significant hypersensitivity to any drug.
  • Any protocol-required laboratory test abnormality that is considered clinically significant.
  • Mentally unstable or incompetent.
  • Any illness during the week before.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00648869

Locations
Israel
Diabetes Unit, Hadassah Hebew University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Itamar Raz, MD Hadassah Hebrew University Hospital
  More Information

No publications provided

Responsible Party: Prof. Itamar Raz, Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00648869     History of Changes
Other Study ID Numbers: generex-HMO-CTIL
Study First Received: March 27, 2008
Last Updated: October 25, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
pharmaceutical preparations

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

ClinicalTrials.gov processed this record on June 18, 2013