PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA

Exclusion Criteria

• •Abnormal findings on physical examination, EKG, vital signs, and clinical laboratory testing, in the judgment of the investigator;
• •Allergies to fish or shellfish;
• •Impaired renal function (calculated eGFR \<60 mL/min);
• •Abnormal laboratory values for T3, T4 and TSH at the Screening Visit;
• •Aspartate aminotransferase/alanine aminotransferase (AST/ALT) \>2x upper limits of normal (ULN) or serum bilirubin \>1.5 mg/dL;
• •Requirement of prescription medication within 14 days of the Screening Visit, with the exception of prescription medications for the prevention of pregnancy, anti hypertensives for hypertension, or statins for hyperlipidemia. Doses of one or two anti-hypertensives and/or a statin must be stable for \>1 month;
• •Normal doses of over-the-counter medications, including vitamins are allowed but not within 3 days of Visit 2 (first day of dosing);
• •Current or history of abuse of alcohol or illicit drugs within the preceding year to the Screening Visit;
• •Participation in a dietary modification or an intensive weight loss program;
• •Participation in another clinical trial of an investigational product within 3 months prior to the Screening Visit;
• •Smokers (use of tobacco in the past 3 months); or,
• •Donation or loss of 400 mL blood or more in the last 8 weeks.