None listed
Conditions
Interventions
Drug : The investigational products used in this study are esomeprazole capsules (40 mg), Banhasasim-tang soft extract (Kyungbang Pharmaceutical), and Pyeongwi-san soft extract (Kyungbang Pharmaceutic
however, the order of administration of Banhasasim-tang and Pyeongwi-san will be reversed.
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female adults aged 19 to 50 years at the time of screening. 2. Subjects with a body mass index (BMI) between 17.5 kg/m² and 30.5 kg/m², with a body weight of =55 kg for males and =45 kg for females. Ideal body weight (IBW, kg) = (height in cm - 100) × 0.9. 3. Subjects with no congenital diseases or chronic diseases within the past three years, and who show no clinically significant findings or pathological symptoms based on medical history and physical examination. 4. Subjects who are determined by the investigator to be eligible for participation based on screening evaluations, including laboratory tests (hematology, blood chemistry, urinalysis, viral/bacterial tests), vital signs, and electrocardiogram (ECG), conducted according to the characteristics of the investigational products. 5. Subjects who voluntarily agree to participate in this clinical trial and provide written informed consent after receiving a full explanation and demonstrating a complete understanding of the study and its requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects with clinically significant diseases or a history of diseases involving the hepatobiliary, renal, gastrointestinal, respiratory, hematologic/oncologic, endocrine, genitourinary, neuropsychiatric, musculoskeletal, immune, otorhinolaryngologic, or cardiovascular systems (except for simple dental conditions such as dental calculus, impacted teeth, or wisdom teeth). 2. Subjects with a history of gastrointestinal diseases that may affect drug absorption (e.g., achalasia, esophageal stricture, Crohn’s disease, peptic ulcer disease, acute or chronic pancreatitis) or gastrointestinal surgery (except for simple appendectomy, hernia repair, or tooth extraction). 3. Subjects with peptic ulcer disease within the past 3 months or those who have continuously taken gastric acid–suppressive agents (e.g., proton pump inhibitors [PPIs], H2 receptor antagonists) for 4 weeks or longer. 4. Subjects with a history of drug hypersensitivity or any type of adverse reaction (including dermatologic reactions) such as anaphylaxis. 5. Subjects with a history of cardiovascular diseases (e.g., arrhythmia, ischemic heart disease) or abnormal findings on electrocardiogram (ECG) that may increase the risk when esomeprazole or herbal medicines are co-administered. 6. Subjects with active severe psychiatric disorders identified through recent medical records or interviews (e.g., acute psychotic symptoms, mania, severe suicidal risk) that may interfere with compliance with study procedures. 7. Subjects suspected of having a bleeding tendency based on blood or urine tests. Mild abnormalities may be re-evaluated and considered eligible if normalized upon retesting; final eligibility will be determined by the investigator. Specific criteria include: Hemoglobin (Hb) 10/HPF. 8. Subjects with AST or ALT greater than twice the upper limit of normal (ULN) or total bilirubin greater than twice the ULN. 9. Subjects with estimated glomerular filtration rate (eGFR, CKD-EPI) 140 mmHg or 90 mmHg or 21 units/week; 1 unit = 10 g of pure alcohol) or are unable to abstain from alcohol during the study period (e.g., 1 shot of soju [50 mL, 20%] or 1 glass of beer [200 mL, 5%] ˜ 10 g alcohol). 17. Subjects with a history of drug abuse or addiction, or those s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration–time curve from time zero to the last measurable concentration (AUC0–t) of esomeprazole;Area under the plasma concentration–time curve from time zero to infinity (AUC0–8) of esomeprazole;Maximum plasma concentration (Cmax) of esomeprazole | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach maximum plasma concentration (Tmax) of esomeprazole;Incidence and severity of adverse events (classified according to System Organ Class [SOC] and Preferred Term [PT]);Changes in diagnostic laboratory test results;Changes in vital signs;Changes in 12-lead electrocardiogram (ECG) | — |
Countries
Korea, Republic of
Contacts
Public ContactDong-Hyeon Kim
Pusan National University Korean Medicine Hospital
Outcome results
None listed