[Translation] A single-center, randomized, open, parallel, active-drug controlled trial to evaluate the safety, tolerability, and pharmacokinetics of quadruple therapy with keprashen hydrochloride tablets and quadruple therapy with esomeprazole magnesium enteric-coated tablets
主要目的:
评估盐酸凯普拉生片四联疗法(联合克拉霉素片、阿莫西林胶囊、枸橼酸铋钾胶囊)的药物相互作用,考察枸橼酸铋钾胶囊在不同给药组的药代动力学差别。
次要目的:
评估盐酸凯普拉生片四联疗法(联合克拉霉素片、阿莫西林胶囊、枸橼酸铋钾胶囊)与艾司奥美拉唑镁肠溶片四联疗法(联合克拉霉素片、阿莫西林胶囊、枸橼酸铋钾胶囊)的安全性。
[Translation] Primary objective:
To evaluate the drug interactions of quadruple therapy of Caprasin hydrochloride tablets (combined with clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules), and to investigate the pharmacokinetic differences of bismuth potassium citrate capsules in different dosing groups.
Secondary objective:
To evaluate the safety of quadruple therapy of Caprasin hydrochloride tablets (combined with clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules) and quadruple therapy of esomeprazole magnesium enteric-coated tablets (combined with clarithromycin tablets, amoxicillin capsules, and bismuth potassium citrate capsules).