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Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00648869
Recruitment Status : Withdrawn (Drug was not sent)
First Posted : April 1, 2008
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: metformin tablet, metformin gum Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers
Study Start Date : June 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: metformin tablet, metformin gum
    500 mg, 250 mg


Primary Outcome Measures :
  1. To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet). [ Time Frame: 45 days ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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.

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): 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

Responsible Party: Prof. Itamar Raz, Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00648869     History of Changes
Other Study ID Numbers: generex-HMO-CTIL
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: March 2008

Keywords provided by Hadassah Medical Organization:
pharmaceutical preparations

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