None listed
Conditions
Interventions
Drug : Part A : On an empty stomach to 15 healthy subjects, 10000mg of metformin is administered morning and evening over and over again, followed by stage 2 (12d - 21d) red ginseng concentrate. Mix 2
Sponsors
Kyungpook National University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy Korean male adult aged = 19 years at screening 2) Body Mass Index (BMI)=18.5 kg/m2~27.0 kg/m2 at screening 3) No abnormal symptom or sign, based on medical history and physical examination, with no congenital or chronic disease 4) Subject that is considered eligible to participate in the study by an investigator, based on clinical laboratory test (serology, hematology, biochemistry, urinalysis) and 12-lead electrocardiography, conducted within 4 weeks prior to administration of study drug 5) Subjects who understands a detailed explanation about the study, voluntarily decides to participate and comply with instructions and signs informed consent
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to study drug (major ingredient or any other ingredient), or medical history of clinically significant hypersensitivity to any other drug or additives 2) Medical history or evidence (hepatobiliary, renal, cardiovascular, endocrine, respiratory,gastrointestinal, hemato-oncology, central nervous system, psychiatric and musculoskeletal system) that can affect absorption, distribution, metabolism and excretion of a given drug 3) Patient with type I diabetes (history of ketonemia), presence or history of diabetic ketonemia, diabetic coma 4) Use of intravenous radiocontrast containing iodine (intravenous urography, intravenous cholangiography, angiography, Computed Tomography scan with contrast) within 1 week prior to study medication administration 5) Presence of gastrointestinal disease (e.g., inflammatory bowel disease, active peptic ulcer) or history of gastrointestinal resection surgery (excluding simple appendectomy or herniorrhaphy) that can affect absorption of the study drug 6) Presence or history of major injury, surgical operation, or suspected symptom of acute disease (severe infection, severe trauma, serious diarrhea or vomiting) within 4 weeks prior to the first administration of the study drug 7) Subject with a history of drug abuse 8) Use of any prescription medication or herbal remedies within the previous 2 weeks,or use of any over-the-counter remedies such as probiotics or omega-3 within 1 week prior to the first administration of the study drug, as this could have affected the study or the safety of the subjects in the opinion of the investigator 9) Participation in any other clinical study involving administration of either an investigational or a marketed drug within 3 months prior to the first administration of the study drug (the completion date of previous study is the day of the last administration of the study drug) 10) Donation of whole blood within 2 months or any blood products within 1 month prior to the first administration of the study drug 11) History of excessive alcohol abuse (> 21units/week, 1 unit = 10g = 12.5mL of pure alcohol), or subjects who cannot abstain from drinking during the study period, or excessive smoking (> 10 cigarettes per day) 12) Abnormal diet that can affect absorption, distribution, metabolism and excretion of the study drug (e.g., consumption of grapefruit juice(= 1L/day) within 7 days prior to study medication administration) 13) Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL) 14) Subject who is planning a pregnancy or cannot use of an accepted method of contraception during the study 15) Subject who is not eligible to participate at the discretion of the principal investigator and study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration of Metformin;Blood concentration of Ginsenoside Rb1, compound K | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: vital sign;Part B: vital sign;Part A: physical examination;adverse event | — |
Countries
Korea, Republic of
Contacts
Public ContactKim REUM
Kyungpook National University Hospital
Outcome results
None listed