None listed
Conditions
Interventions
Drug : - Treatment A: Rabeprazole 20 mg administered alone once daily.
- Treatment B: Kyungbang Banhasasim-tang Soft Extract 10 g/sachet administered three times daily for 5 days, followed by coadmini
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy adults aged 19–50 years at screening. (2) BMI =17.5 and <30.5 kg/m², with body weight =55 kg for men and =45 kg for women. (3) No congenital disease or chronic disease within the previous 3 years, and no clinically significant symptoms or findings on medical examination. (4) Considered eligible by the investigator based on screening assessments, including hematology, blood chemistry, urinalysis, viral/bacterial tests, vital signs, and electrocardiography. (5) Voluntary written informed consent provided after receiving adequate information about the purpose and procedures of the study, using an informed consent form approved by the Jeonbuk National University Hospital IRB. (6) Agreement to use appropriate contraception throughout the study; male participants must also agree not to donate sperm until 1 month after the final dose of the investigational products. (7) Able and willing to participate throughout the study period.
Exclusion criteria
Exclusion criteria: (1) History or evidence of clinically significant hematologic, renal, endocrine, respiratory, gastrointestinal, genitourinary, cardiovascular, hepatic, psychiatric, neurologic, or immune disease, excluding minor dental conditions such as dental calculus, impacted teeth, or wisdom teeth. (2) History of gastrointestinal disease or surgery that may affect drug absorption, including esophageal disorders such as achalasia or esophageal stricture, or Crohn’s disease; uncomplicated appendectomy, hernia repair, and tooth extraction are excluded. (3) ALT or AST >2 times the upper limit of normal at screening. (4) Regular alcohol consumption exceeding 210 g/week within 6 months before screening. (5) Use of another investigational product or bioequivalence study drug within 6 months before the first dose. (6) History of significant alcohol or drug abuse within 1 year before screening. (7) Use of drugs known to markedly induce or inhibit drug-metabolizing enzymes within 30 days before the first dose. (8) Smoking =20 cigarettes/day within 6 months before screening. (9) Use of prescription drugs, nonprescription drugs, herbal medicines, or health supplements within 10 days before the first dose. (10) Whole-blood donation within 2 months or apheresis donation within 1 month before the first dose. (11) Severe acute or chronic medical or psychiatric condition that may increase study-related risk or interfere with interpretation of the results. (12) Known hypersensitivity to any active ingredient or component of the investigational products, benzimidazole derivatives, other medicines, or herbal medicines. (13) Hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, or similar hereditary disorders. (14) Current treatment with atazanavir. (15) Severe hepatic impairment (Child-Pugh Class C). (16) Pregnant or breastfeeding women. (17) Postmenopausal women. (18) Unwilling or unable to comply with the participant management requirements specified in the protocol. (19) Any other condition considered by the investigator to make the individual unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCt of Rabeprazole;Cmax of Rabeprazole | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf of Rabeprazole;Tmax of Rabeprazole;t1/2 of Rabeprazole;CL/F of Rabeprazole;Vd/F of Rabeprazole | — |
Countries
Korea, Republic of
Contacts
Public ContactSeol Ju Moon
Jeonbuk National University Hospital
Outcome results
None listed