Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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metformin tablet, metformin gum

500 mg, 250 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes