Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

• Status: Withdrawn
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Metformin

Criteria

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.