None listed
Conditions
Interventions
Drug : This clinical trial shall be conducted in a public, single dosing group, and 1 ordered group.
• Experimental group: The maximum allowed dose is administered once a day on a day on an empty sto
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 90 mmHg or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUCt;Evaluation of safety - adverse events, vital signs, physical examination, electrocardiogram tests, and clinical laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf;Time of maximum concentration, tmax;Creatine Phophokinase, CL/F | — |
Countries
Korea, Republic of
Contacts
Public ContactSoo-Dam Kim
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed