Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

Healthy Clinical Trial

Official title:

Open-label,Randomized, Crossover Study Comparing Metformin Gum and Immediate Release Tablet in Healthy Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00648869
• Other study ID #: generex-HMO-CTIL
• Status: Withdrawn
• Phase: N/A
• First received: March 27, 2008
• Last updated: October 25, 2009
• Start date: June 2008
• Est. completion date: November 2008

Study information

• Verified date: March 2008
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 12
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• metformin tablet, metformin gum
500 mg, 250 mg

Locations

Country	Name	City	State
Israel	Diabetes Unit, Hadassah Hebew University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).		45 days	No
Secondary	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	No