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Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study

Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study - Acid-inhibitory effects of vonoprazan compared with rabeprazole in healthy adult subjects - a randomised open-label cross-over study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022198
Enrollment
30
Registered
2016-06-01
Start date
2016-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy subjects

Interventions

Subjects are administrated rabeprazole 20mg after administrated vonoprazan 20mg. Subjects are administrated vonoprazan 20mg after administrated rabeprazole 20mg. Subjects are administrated rabeprazole

Sponsors

Osaka medical collage
Lead Sponsor
Gunma University,Yokohama City University,Hamamatsu University School of Medicine,Aichi Medical University,Osaka City University,Saga University,Oita University,University of Miyazaki,Shiga University of Medical Science,Okayama University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 20 years of age or more

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactYuichi Kojima

Osaka medical collage second department of internal medicine

in2134@osaka-med.ac.jp0726831221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026