Status:
WITHDRAWN
Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00648869
Start Date
June 1 2008
End Date
November 1 2008
Last Update
October 27 2009
Active Locations (1)
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1
Diabetes Unit, Hadassah Hebew University Hospital
Jerusalem, Israel, 91120