Clinical trial: A Study to Evaluate the Effect of Food on Fixed-Dose Combination of MP-513 10 mg and Metformin XR 750 mg (NCT03787043)

Eligibility criteria:
Inclusion Criteria:

          -  A healthy male adult at the age of 20 to 45 (both inclusive) at the time of screening
             test.

          -  Body weight equal to or greater than 55 kg and calculated ideal body weight (IBW)
             within ±20%

          -  An individual who has been given and fully understood detailed explanations about this
             study, decides to participate in the study of his own will, and provides written
             informed consent to comply with instructions.

        Exclusion Criteria:

          -  History or presence of any clinically significant diseases in the hepatobiliary,
             renal, nervous(central or peripheral), respiratory, hemato-oncology, cardiovascular,
             urinary, musculoskeletal, immune, ear, nose and throat (ENT), mental, and,
             particularly, endocrine systems (e.g., diabetes mellitus, hyperlipidemia, etc.).

          -  History of any gastrointestinal disease that may affect absorption of the study drug
             (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal
             surgeries (except for simple appendectomy or hernia repair).

          -  Hypersensitivity to MP-513 or drugs containing metformin or other drugs in the same
             class as ingredients or to other drugs

          -  Vital signs in a sitting position corresponding to at least one of the following
             criteria: systolic blood pressure ≥ 140 mmHg or < 90 mmHg, or diastolic blood pressure
             ≥ 95 mmHg or < 60 mmHg.

          -  Serum creatine > upper limit of reference range

          -  Required to refrain from food intake for at least 24 hours during the study period due
             to surgery or religious reason.

          -  History or presence of drug abuse.

          -  Administration of drugs that either induce or inhibit drug metabolizing enzymes, such
             as barbitals, within 1 month prior to the first dosing.

          -  Intake of food or beverage containing grapefruit or cranberry within 1 week prior to
             the first dosing.

          -  Administration of any ethical drugs or traditional Korean herbal medicines within 2
             weeks or any over-the-counter drugs or vitamin products within 1 week prior to the
             first dosing

          -  An individual who participated in another clinical trial and was administered any
             investigational product within 3 months prior to the first dosing.

          -  Whole blood donation within 2 months, apheresis donation within 1 month, or blood
             transfusion within 1 month prior to the first dosing.

          -  An individual who drinks excessive amounts of alcohol or who cannot stop drinking
             alcohol from 24 hours prior to hospital admission through to hospital discharge.

          -  Having smoked 10 cigarettes/day or more on average over the past 3 months.
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction