Effect of gastric acid inhibitor on drug metabolism

JRCT ID: jRCTs041220044

Registered date:15/07/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: None
• Date of first enrollment: 03/03/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

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 10mg 1 tablet 1 after dinner+oral administration with Coca-Cola 200ml
All study subjects were first given a 13C-aminopyrine breath test with water as a control.
The study drug will be taken orally for 8 days, with a washout period of 14 days, and when changing to another drug, a washout period of 14 days will be allowed before the next dose.
Patients will come to the clinic before dinner consumption on the 8th day of medication, take 13C-aminopyrine and the study drug before dinner consumption at the designated place, and perform a breath test.
Breath will be taken before and 15, 30, 45, 60, 75, 90, 105, 120, 150, and 180 minutes (11 times) after taking 13C-aminopyrine and each study drug, respectively.

Outcome(s)

• Primary Outcome: Carbon isotope ratio (13CO2/12CO2) of carbon dioxide in 13C-aminopyrine breath samples after VPZ and EPZ oral administration
• Secondary Outcome: Frequency of adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Mihoko Yamade