Clinical trial: inhibitory effect of revaprazan on gastric acid secretion in healthy male subjects

  • J Gastroenterol Hepatol. 2010 Oct;25(10):1618-25. doi: 10.1111/j.1440-1746.2010.06408.x.
Hyung-Keun Kim  1 ,  Soo-Heon Park ,  Dae-Young Cheung ,  Young-Seok Cho ,  Jin-Il Kim ,  Sung-Soo Kim ,  Hiun-Suk Chae ,  Jae-Kwang Kim ,  In-Sik Chung
Affiliations
  • 1. Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Yeongdeungpo-gu, Seoul.
PMID: 20880169 DOI: 10.1111/j.1440-1746.2010.06408.x
Abstract

Background and aim: Revaprazan is a novel acid pump antagonist. The aim of this study was to investigate the inhibitory effect of revaprazan on gastric acid secretion in healthy male subjects.

Methods: In a double-blind, three-way cross-over study, 30 healthy male volunteers were randomized to 100, 150 or 200 mg of oral revaprazan daily for 7 days. Serum Gastrin concentration was measured, and 24-h intragastric pH was recorded at baseline and on days 1 and 7 of each administration period. Serial blood samples were processed for pharmacokinetics.

Results: Median intragastric pH over 24 h and mean percentage time that pH was > 4 increased in a dose-dependent manner and were significantly higher on days 1 and 7 compared with baseline in all groups (P < 0.05). The antisecretory effect of revaprazan was rapid and nearly maximal on day 1 in all groups. Serum Gastrin levels were rapidly normalized by 100 and 150 mg/day of revaprazan on days 1 and 7, but were significantly higher in the 200 mg/day revaprazan group. The pharmacokinetic effect was rapidly absorbed and eliminated on days 1 and 7 in all groups.

Conclusions: Revaprazan rapidly and effectively inhibits gastric acid secretion in healthy male subjects. Therefore, revaprazan can be used as an effective drug for acid-related disease.

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