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.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Esophagitis, Peptic / drug therapy*
  • Esophagitis, Peptic / metabolism
  • Follow-Up Studies
  • Gastric Acid / metabolism*
  • Gastric Acidity Determination
  • Gastric Mucosa / metabolism*
  • Humans
  • Male
  • Peptic Ulcer / drug therapy*
  • Peptic Ulcer / metabolism
  • Proton Pump Inhibitors / administration & dosage*
  • Reference Values
  • Stomach / drug effects

Substances

  • Proton Pump Inhibitors