作者
Sungpil Han, Hee Youn Choi, Yo Han Kim, Ji Yeon Nam, Bongtae Kim, Geun Seog Song, Hyeong‐Seok Lim, Kyun‐Seop Bae
发表日期
2019/10
期刊
Alimentary pharmacology & therapeutics
卷号
50
期号
7
页码范围
751-759
简介
Background
Tegoprazan (CJ‐12420) is a potassium‐competitive acid blocker (P‐CAB) with therapeutic potential for gastro‐oesophageal reflux disease (GERD) by reversibly suppressing gastric H+/K+‐ATPase.
Aims
To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of tegoprazan
Methods
A phase I, randomised, double‐blind and placebo‐controlled clinical trial was conducted in 56 healthy male subjects without Helicobacter pylori infection. In the single ascending dose study, 50, 100, 200 and 400 mg tegoprazan were administered to 32 subjects. In the multiple ascending dose study, 100 and 200 mg tegoprazan were administered every 24 hours to each of the eight subjects for 7 days. In the comparative pharmacodynamics study, 40 mg esomeprazole was administered to eight subjects every 24 hours for 7 days. The assessment included safety, tolerability, pharmacodynamics …
引用总数
2019202020212022202320241414122210