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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT00648869
First Posted: April 1, 2008
Last Update Posted: October 27, 2009
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:
Hadassah Medical Organization
March 27, 2008
April 1, 2008
October 27, 2009
June 2008
October 2008   (Final data collection date for primary outcome measure)
To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet). [ Time Frame: 45 days ]
Same as current
Complete list of historical versions of study NCT00648869 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy
Drug: metformin tablet, metformin gum
500 mg, 250 mg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
12
November 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00648869
generex-HMO-CTIL
Yes
Not Provided
Not Provided
Prof. Itamar Raz, Hadassah Medical Organization, Jerusalem, Israel
Hadassah Medical Organization
Not Provided
Principal Investigator: Itamar Raz, MD Hadassah Hebrew University Hospital
Hadassah Medical Organization
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP