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WithdrawnNCT00648869Updated Oct 27, 2009

Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

An interventional study of metformin tablet, metformin gum in Healthy, sponsored by Hadassah Medical Organization. Withdrawn at 1 site in Israel. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-10-27.

Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Drug was not sent
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Healthy

Keywords

  • pharmaceutical preparations
03

In context

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Interventions

  • Drugmetformin tablet, metformin gum

    500 mg, 250 mg

06

What researchers measure

Primary outcomes

  1. To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).

    Time frame: 45 days

Secondary outcomes

  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

07

Study locations

1 site
  • Diabetes Unit, Hadassah Hebew University Hospital
    Jerusalem, 91120, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00648869
Lead sponsor
Hadassah Medical Organization
First posted
Apr 1, 2008
Start date
Jun 2008
Primary completion
Oct 2008 (estimated)
Completion
Nov 2008 (estimated)
Last update
Oct 27, 2009

Study contacts

Itamar Raz, MD
principal investigator · Hadassah Hebrew University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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