Pharmacokinetics and Pharmacodynamics of Tegoprazan Coadministered With Amoxicillin and Clarithromycin in Healthy Subjects
Abstract
Abstract This clinical trial was conducted to evaluate the pharmacokinetics and pharmacodynamics of tegoprazan when coadministered with amoxicillin/clarithromycin in healthy subjects. Cohort 1 was an open‐label, randomized multiple‐dose study to evaluate the mutual interaction of tegoprazan and amoxicillin/clarithromycin on the disposition of 3 tested drugs including tegoprazan M1 metabolite and 14‐hydroxyclarithromycin (14‐OH‐clarithromycin). Cohort 2 was an open‐label, randomized, active‐controlled, parallel multiple‐dose study to compare the intragastric pH profile after multiple oral doses of 50 or 100 mg tegoprazan coadministered with amoxicillin/clarithromycin 1000/500 mg for 7 days and pantoprazole‐based triple therapy as the comparator arm. The coadministration of tegoprazan with amoxicillin/clarithromycin increased C ss,max (2.2‐fold) and AUC τ (2.7‐fold) of tegoprazan and M1 (2.1‐ and 2.2‐fold for C ss,max and AUC τ , respectively) compared with administration of tegoprazan alone. The C ss,max and AUC τ of 14‐OH‐clarithromycin increased by 1.7‐ and 1.8‐fold, respectively; the disposition of amoxicillin and clarithromycin were not significantly changed. On days 1 and 7 of treatment, tegoprazan‐based therapies (both 50‐ and 100‐mg therapies) maintained pH above 6 for more than 88% of the 24‐hour period, which was significantly longer compared with pantoprazole‐based therapy. Tegoprazan either alone or in combination with amoxicillin/clarithromycin was well tolerated…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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