Clinical trial: PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA (NCT02113163)

Eligibility criteria:
Inclusion Criteria:

          -  Signed informed consent executed prior to protocol screening assessments;

          -  Men or women 18 to 65 years of age, inclusive (Women may be surgically sterile via
             tubal ligation, bilateral oophorectomy or hysterectomy or who are postmenopausal for
             >1 year. Women who are of childbearing potential must agree to practice adequate
             contraception one month before the first dose of study medication and up to Day 16 of
             the study. Adequate contraception may include, but is not limited to, abstinence,
             monogamous relationship with vasectomized partner, barrier methods such as condoms or
             diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal
             methods.);

          -  No history of chronic diseases, except for subjects with well-controlled hypertension
             or well-controlled hyperlipidemia;

          -  BMI ≤30kg/m2;

          -  No significant medical history including diabetes or hypertension complicated by
             hyperlipidemia (metabolic syndrome);

          -  Negative urine drug and alcohol tests at Screening; and,

          -  No metformin or omega-3 products within 2 months.

        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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment