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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014