Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

Hadassah Medical Center

Status

Withdrawn

Conditions

Healthy

Treatments

Drug: metformin tablet, metformin gum

Study type

Interventional

Funder types

Other

Identifiers

generex-HMO-CTIL

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.