A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With Vonoprazan Versus Quadruple Therapy With Esomeprazole

Detailed Summary

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.

Study Details

Timeline

Interventions