Clinical trials for the study of human pharmacokinetics of HAD-B1 (Boswellia carteri, Panax Notoginseng, Panax ginseng, Cordyceps militaris)
- Conditions
- Not Applicable
- Registration Number
- KCT0006489
- Lead Sponsor
- Daejeon Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 15
1. Healthy adult males aged between 19 and 45 years of age at the time of screening
2. A person weighing 55 kg or more and within ±20% of the Ideal Body Weight (IBW) ? Ideal Body Weight (IBW, kg) = (Height (cm) - 100) × 0.9
3. A person who has no birth or chronic disease. Upon internal examination, a person who shows no morbid symptoms, or abnormal findings
4.A person who voluntarily decides to participate and agrees to comply with the precautions, after hearing the detailed explanation of this clinical trial and fully understanding it.
1. A person who has clinical significance in the hepatobiliary system, kidney, digestive system, respiratory system, blood/tumor system, endocrine system, urinary system, neuropsychiatry, musculoskeletal system, immune system, otolaryngeal system, cardiovascular system, or has a medical history regarding these.
2. A person with a past medical history of gastrointestinal disease (such as Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of test drugs.
3. A person with a history of hypersensitivity or clinically significant hypersensitivity to the components of HAD-B1 or other components contained in this drug.
4. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder
5. In the vital signs measured in the sitting position, whose systolic blood pressure is > 140 mmHg or <100 mmHg, and whose dilator blood pressure > 90 mmHg or <60 mmHg, pulse rate 100 100 times/min.
6. A person whose AST or ALT exceeds twice the upper limit of the reference range, or whose total bilirubin exceeds twice the upper limit of the reference range.
7. Neophilic patients (who have a creatinine cleaning rate is less than 50 mL/min calculated by Cockcroft-Gault)
8. Past history of drug abuse or positive drug screening tests
9. A person who has taken medication metabolic enzyme-inducing and inhibiting drugs, such as barbitide medication, within one month prior to the first dose.
10. If a specialized drug (ETC drug) or herbal medicine was taken within two weeks prior to the first dose, or if a generic drug (OTC drug) or vitamin supplement was taken within one week, or the drug was determined to affect the safety of the test subject, according to the tester's judgment.
11. A person who participated in another clinical trial within 6 months prior to the date of the first dose and administered the medication for the clinical trial.
12. A person who donated whole blood within two months before the first dose, or donated ingredients within one month of the first dose, or received a blood transfusion within one month before the first dose.
13. Those who continue to drink excessively (21 units/week; 1 unit = 10 g of pure alcohol) or are unable to abstain from discharge 24 hours before hospitalization.
(Reference: 20°C soju (%) 50 ml -> 10 g / 5°C beer (%) 200 ml -> 10 g
So 1 unit -> soju, 1 beer)
14. Smokers with an average of more than 10 cigarettes per day in the last 3 months.
15. Dental treatment (feet, braces, neurological treatment, etc.) and selective surgery (beauty surgery, lasik, lasek, etc.) from the time of signing the consent form to post-study visit are scheduled or unable to be postponed.
16. A person who is deemed unfit to participate in a clinical trial due to the results of a clinical laboratory examination and other reasons.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax;AUCt;Evaluation of safety - adverse events, vital signs, physical examination, electrocardiogram tests, and clinical laboratory tests
- Secondary Outcome Measures
Name Time Method AUCinf;Time of maximum concentration, tmax;Creatine Phophokinase, CL/F