Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other parts of the digestive system. Vonoprazan is a medicine to treat people with H Pylori. It is taken together with other medicines to fight infections caused by H Pylori. The main aim of this study is to learn if vonoprazan changes how the other medicines are processed by the body. It will be compared with another medicine called esomeprazole. Other aims are to check for side effects from the study medicines. At the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 2 treatments by chance. * Vonoprazan taken with bismuth, clarithromycin, and amoxicillin * Esomeprazole taken with bismuth, clarithromycin, and amoxicillin Both treatments will last for 14 days. Participants will stay in the clinic throughout their treatment. After treatment, the clinic staff will telephone the participants 2 days later for a check-up. The participants will visit the clinic 4 weeks later for a final check-up.
This is a study in healthy participants with Helicobacter pylori (HP positive) to evaluate the safety, tolerability and PK of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and vonoprazan versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and esomeprazole. The treatment phase consists of quadruple therapy twice daily (BID) with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and vonoprazan (20 mg) (Group B) or quadruple therapy BID with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after all procedures have been performed. This single-center will be conducted in China. Participants will remain confined to the study site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
44
Clarithromycin tablets.
Amoxicillin capsules.
Bismuth potassium citrate tablets.
Esomeprazole tablets.
Vonoprazan tablets.
West China Hospital, Sichuan University, Phase I Unit
Chengdu, Sichuan, China
Cmax: Maximum Observed Plasma Concentration for Bismuth
Time frame: Day 14: 0 to 12 hours after the morning dose
AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval τ for Bismuth
Time frame: Day 14: 0 to 12 hours after the morning dose
Aeτ: Total Amount of Bismuth Excreted in Urine During a Dosing Interval τ for Bismuth
Time frame: Day 14: 0 to 12 hours after the morning dose
Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Time frame: From the first dose of study drug up to Day 17
Percentage of Participants Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event (TEAE)
Time frame: From the first dose of study drug up to Day 17
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