A study to investigate the interaction between red ginseng and metformin/probiotics in healthy adults

Not Applicable

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0003035
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 21

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood concentration of Metformin;Blood concentration of Ginsenoside Rb1, compound K

Secondary Outcome Measures

Name	Time	Method
Part A: vital sign;Part B: vital sign;Part A: physical examination;adverse event