Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

October 25, 2009 updated by: Hadassah Medical Organization

Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Diabetes Unit, Hadassah Hebew University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Itamar Raz, MD, Hadassah Hebrew University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Anticipated)

October 1, 2008

Study Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2009

Last Update Submitted That Met QC Criteria

October 25, 2009

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • generex-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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