None listed
Conditions
Interventions
Drug : Part1 sequence1: rabeprazole 20 mg PO QD x 7 days -> wash-out 10 days -> zastaprazan 20 mg PO QD x 7 days, inpatient administration
Part1 sequence2: zastaprazan 20 mg PO QD x 7 days -> wash-out
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult volunteers aged 19 to 50 years, inclusive, at the time of screening 2. Individuals with a body weight of 50.0 to 95.0 kg, inclusive, and a body mass index (BMI) of 18.5 to 29.9 kg/m², inclusive, at the time of screening * Body mass index (BMI, kg/m²) = body weight (kg)/{height (m)}² 3. Female volunteers who are not pregnant or breastfeeding, or who are surgically sterile * Pregnancy status shall be confirmed by a urine pregnancy test (urine hCG). * Surgical sterility is defined as having undergone procedures such as bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy. 4. Individuals who test negative for Helicobacter pylori antibodies 5. Individuals considered suitable for participation in this clinical trial by the investigator based on medical history, physical examination, clinical laboratory tests, vital signs, electrocardiography, and other relevant assessments 6. Individuals who, after receiving a sufficient explanation of the clinical trial and fully understanding its contents, voluntarily decide to participate, provide written informed consent, and agree to comply with all study requirements and precautions
Exclusion criteria
Exclusion criteria: 1. Individuals with a current or past history of clinically significant disease involving the hepatobiliary system (e.g., moderate or severe hepatic impairment or viral hepatitis), kidneys (e.g., moderate or severe renal impairment), nervous system, immune system, respiratory system, gastrointestinal system, endocrine system, hematologic or oncologic system, cardiovascular system (e.g., heart failure or torsades de pointes), genitourinary system, psychiatric system (e.g., mood disorders or obsessive-compulsive disorder), or sexual dysfunction 2. Individuals with a history of diagnosis or treatment for acute gastritis, chronic gastritis, gastroesophageal reflux disease, or peptic ulcer disease, or who are suspected of having any such condition based on relevant signs or symptoms 3. Individuals with a current or past history of a gastrointestinal disease that may affect the safety, pharmacokinetic, or pharmacodynamic evaluation of the investigational products, including Crohn’s disease, gastrointestinal ulcer, acute gastritis, chronic atrophic gastritis, gastric spasm, gastroesophageal reflux disease, or achlorhydria, or a history of gastrointestinal surgery, except for uncomplicated appendectomy or hernia repair, or who are suspected of having any such condition based on relevant signs, symptoms, or medication history 4. Individuals in whom insertion or maintenance of the pH-monitoring probe is not feasible due to an anatomical abnormality 5. Individuals with a history of hypersensitivity to rabeprazole, drugs of the same class, or benzimidazole derivatives, or in whom clinically significant hypersensitivity to any such drug is suspected * Drugs in the same class as rabeprazole include omeprazole, esomeprazole, lansoprazole, and pantoprazole. * Benzimidazole derivatives include mebendazole, albendazole, thiabendazole, ketoconazole, and clotrimazole. 6. Individuals with a history of hypersensitivity to zastaprazan or drugs of the same class, or in whom clinically significant hypersensitivity to any such drug is suspected * Drugs in the same class as zastaprazan include vonoprazan, tegoprazan, fexuprazan, and revaprazan. 7. Individuals with a history of hypersensitivity to any other drug, including aspirin or antibiotics, or to any food, or in whom clinically significant hypersensitivity is suspected 8. Individuals with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 9. Individuals with a positive serologic test result for hepatitis B, hepatitis C, or human immunodeficiency virus infection 10. Individuals with a history of drug abuse or a positive urine drug-screening test for drugs of abuse 11. Individuals with any of the following clinical laboratory test results during screening, including any additional testing: * Serum AST (SGOT) or ALT (SGPT) >60 IU/L * Serum ALP >172 IU/L * Serum total bilirubin >1.8 mg/dL * Estimated glomerular filtration rate calculated using the CKD-EPI equation 100 beats/min 13. Individuals with any of the following electrocardiographic findings during screening: * PR interval >210 ms * QRS duration >120 ms * QT interval >480 ms * QTcB interval >450 ms for male participants * QTcB interval >470 ms for female participa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gatric pH measured by 24-hour pH monitoring | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic Variability According to the Method of Drug Administration | — |
Countries
Korea, Republic of
Contacts
Public ContactJaegu Kang
Seoul National University Hospital
Outcome results
None listed