West China Hospital, Sichuan University, Phase I Unit
Chengdu, Sichuan, 610041, China
NCT Number: NCT04753437
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Chengdu, Sichuan, 610041, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clarithromycin tablets.
Amoxicillin capsules.
Bismuth potassium citrate tablets.
Esomeprazole tablets.
Vonoprazan tablets.
Other names: TAK-438
Time frame: Day 14: 0 to 12 hours after the morning dose
Time frame: Day 14: 0 to 12 hours after the morning dose
Time frame: Day 14: 0 to 12 hours after the morning dose
Time frame: From the first dose of study drug up to Day 17
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
Takeda
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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