An clinical study to evaluate the drug-drug interaction between herbal medicine(Sosiho-tang) and three chemical drugs in healthy adult volunteers
- Conditions
- Not Applicable
- Registration Number
- KCT0007930
- Lead Sponsor
- Sangji University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 20
1) Healthy adult male between the ages of 19 and 50 at the time of screening
2) Those with a body mass index (BMI) of 17.5 kg/m2 or more and less than 30.5 kg/m2, and weight of 55 kg or more
3) Those who have no congenital or chronic diseases within the last 3 years and no pathological symptoms or findings as a result of medical examination
4) Those who are judged to be suitable as subjects based on screening tests (hematology, blood chemistry, urinalysis, virus/bacteria test, etc.), vital signs, and electrocardiogram
5) A person who has fully explained the purpose and contents of the test before participating in the test, has agreed to participate in this study voluntarily and has signed a written informed consent approved by the Biomedical Research Ethics Review Board (IRB) of Chonbuk National University Hospital
6) Those who have agreed to use an appropriate contraceptive method during the entire clinical trial period and, in the case of men, consented not to provide sperm for 1 month after the last administration date of the investigational drug
7) Those who have the ability and willingness to participate during the entire examination period
1) A history of clinically significant blood, renal, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, or immune disease or pathologic evidence (except for simple dental history of calculus, impacted teeth, wisdom teeth, etc.)
2) A history of gastrointestinal diseases (esophageal diseases such as achalasia or esophageal stricture, Crohn's disease) or gastrointestinal surgery (except simple appendicectomy, hernia surgery, and tooth extraction) that may affect the absorption of clinical trial drugs
3) Those who show the following values ??as a result of the screening test (ALT or AST is twice the upper limit of the normal range)
4) Those with a history of regular alcohol intake exceeding 210 g/week within 6 months of screening (1 glass of beer (5%) (250 mL) = 10 g, 1 glass of soju (20%) (50 mL) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)
5) Those who have taken other clinical investigational drugs or bioequivalence study drugs within 6 months before the first administration of the clinical investigational drug
6) Those with a history of serious alcohol or drug abuse within 1 year of screening
7) A person who has taken a drug known to significantly induce or inhibit drug-metabolizing enzymes within 30 days before the first administration of the clinical trial drug
8) Smokers who smoked more than 20 cigarettes a day within 6 months of screening
9) Those who have taken prescription drugs (including herbal medicines), non-prescription drugs (including herbal medicines), and health functional foods within 10 days before the first administration of clinical trial drugs
10) Those who have donated whole blood within 2 months before the first administration of the clinical trial drug or donated component blood within 1 month
11) Persons with severe acute/chronic medical or mental conditions that may increase the risk due to administration of investigational drugs and participation in the trial or may interfere with the interpretation of test results
12) Patients with allergies or hypersensitivity to the main ingredients and components of clinical investigational drugs
13) Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
14) Patients with platelet count less than 100,000/mm3 due to hepatic dysfunction due to chronic hepatitis (cirrhosis is suspected)
15) Patients with asthma, urticaria, allergic reaction, or history of aspirin or other nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors)
16) Patients with a history of jaundice or liver dysfunction caused by amoxicillin/clavulanate or penicillin
17) Patients with concomitant viral diseases, especially infectious mononucleosis and lymphocytic leukemia
18) Patients with a history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmias (including Torsades de pointes)
19) Patients with severe hepatic impairment
20) hypokalemia patient
21) Patients with severe renal impairment
22) Patients with severe blood abnormalities
23) Postmenopausal women
24) Those who are unwilling or unable to comply with the subject management guidelines described in this plan
25) Others judged by the investigator as inappropriate to participate in this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCt, Cmax of Amoxicillin, clavulanic acid, clartithromycinm and loxoprofen
- Secondary Outcome Measures
Name Time Method AUCinf, Tmax, t1/2, and CL/F of Amoxicillin, clavulanic acid, clartithromycin, and loxoprofen ;AUCt, Cmax, AUCinf, Tmax, and t1/2 of 14-OH clartithromycin, Trans loxoprofen, Hydroxyl loxoprofen;AUCt, AUCt, Cmax, Css,max, AUCinf, Tmax, Tss,max, and t1/2 of Liquiritin, Glycyrrhizin, Baicalin;Evaluation of safety - adverse events, clinical laboratory tests, vital signs, physical examination, and electrocardiogram tests