Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000022198
- Lead Sponsor
- Osaka medical collage
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) by constriction or deformation of the upper gastrointestinal tract, drug administration and the endoscope insertion difficult. 2) there is a history of acid-related diseases. 3) there is a surgical history. 4) there is a history of radiation therapy to the upper abdomen. 5) serious complications(with heart failure, kidney failure, liver failure, respiratory failure). 6) Experience of oral administration of Vonoprazan or Rabeprazole. 7) there is a history of medication to up to one month before the registration date. 8) there is a history eradication of Helicobacter pylori. 9) Helicobacter pylori test positive (anti-HP IgG antibody, urease test, any one is positive urea breath test). 10) There is activity malignant tumor patients and other serious systemic complication. 11) there are abnormal findings in the upper gastrointestinal endoscopy. 12) F scale positive (total score 8 points or more) 13) There is a history of allergy to test drugs 14) pregnancy and lactation. 15) there is a plan of treatment with respect to the upper gastrointestinal tract disease. 16) there is a registration history in the study. 17) can not be obtained the consent to participate in this clinical study. 18) the study director (sharing) who doctor has determined to be inappropriate as a subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate that vonoprazan show a signifcant acid suppressant effect against rabeprazole by comparing an acid suppressant effect on gastric pH (pH holding time at no less than pH3, pH4, and pH5) between vonoprazan and rabeprazole
- Secondary Outcome Measures
Name Time Method Acid suppressant effect by the CYP2C19 genetic polymorphism. Nighttime acid suppressant effect. An incidence of all adverse events. Acid suppressant effect before and after a meal.