Healthy
Conditions
Keywords
pharmaceutical preparations
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
Interventions
DRUGmetformin tablet, metformin gum
500 mg, 250 mg
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet). | 45 days |
Secondary
| 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. | 45 days |
Countries
Israel
Outcome results
None listed