NCT00648869

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

October 27, 2009

Status Verified

March 1, 2008

Enrollment Period

4 months

First QC Date

March 27, 2008

Last Update Submit

October 25, 2009

Conditions

Healthy

Keywords

pharmaceutical preparations

Outcome Measures

Primary Outcomes (1)

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

    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.

    45 days

Interventions

metformin tablet, metformin gumDRUG

500 mg, 250 mg

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Unit, Hadassah Hebew University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Itamar Raz, MD

    Hadassah Hebrew University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2008

First Posted

April 1, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

October 27, 2009

Record last verified: 2008-03

Locations

IL(1)