Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers
Not Applicable
Withdrawn
- Conditions
- Healthy
- Registration Number
- NCT00648869
- Lead Sponsor
- Hadassah Medical Organization
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet). 45 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Diabetes Unit, Hadassah Hebew University Hospital
🇮🇱Jerusalem, Israel