Open-label Crossover Metformin Gum Versus Tablet in Healthy Volunteers

Hadassah Medical Organization12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

metformin tablet, metformin gumDRUG

500 mg, 250 mg

Eligibility

Sex: MALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Diabetes Unit, Hadassah Hebew University Hospital

Jerusalem, Israel

Outcomes

Primary Outcomes

To determine the difference in the pharmacokinetic profile of metformin following administration of two formulations (gum and tablet).

Time frame: 45 days

Secondary Outcomes

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.

Time frame: 45 days

Data from ClinicalTrials.gov

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