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Effect of gastric acid inhibitor on drug metabolism

Evaluation of the effect of Gastric Acid Secretion Inhibitor on Hepatic drug Metabolism by Aminopyrine Breath test

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041220044
Enrollment
20
Registered
2022-07-15
Start date
2023-03-03
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

None

Interventions

Research drug regimen 1)Esomeprazole 20mg 1 tablet 1 after supper +oral administration by 200ml of water 2)Bonoprazan 10mg 1 tablet 1 after supper+oral administration with water 200ml 3)Bonoprazan 10

Sponsors

Mihoko Yamade
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy subjects who are at least 18 years old at the time of consent. Who are able to abstain from alcohol and smoking while taking the study medication and for 14 to 28 days during the washout period Who have signed a consent form to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Those with a history of gastric ulcer 2. Those with a history of myocardial infarction 3. Those with serious liver disease (>3 times the reference value) 4. Patients with serious renal disease (Cre > 1.5) 5. Patients who have undergone abdominal surgery 6. Those who have other serious diseases 7. Who are receiving continuous medical treatment during the study period 8. who are receiving continuous medical treatment during the study period 8. Who are allergic to any of the study drugs (esomeprazole or bonoprazan) 9. Pregnant women and those who wish to deliver a baby during the study period; 10.Persons who are deemed inappropriate by the investigator (subinvestigator).

Design outcomes

Primary

MeasureTime frame
Carbon isotope ratio (13CO2/12CO2) of carbon dioxide in 13C-aminopyrine breath samples after VPZ and EPZ oral administration

Secondary

MeasureTime frame
Frequency of adverse events

Contacts

Public ContactTakahashi Satoru

Hamamatsu University Hospital

41235353@hama-med.ac.jp+81-534352261

Outcome results

None listed

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