Poster Presenter

Twenty-Four Hour Intragastric PH Profiles Pharmacokinetics Following Single and Repeated Oral Administration of Revaprazan, in Helicobacter Pylori Positive Male Subjects
Yong Jai, Park, Soo-Heon, Park, Jin Ho, Kim
South Korea

Introduction: Revaprazan presents a different profile with a reversible mode of action against H⁺/K⁺-ATPase(acid pump) from that of PPIs known for an irreversible mode of action.

Aim: The aim of this study was to investigate the effects of different single and multiple oral doses of the Revaprazan (200, 300, and 400mg) on intragastric pH over 24-h periods and pharmacokinetic in Helicobacter pylori (+)ve male subjects.

Materials and Methods: Twenty nine subjects randomly divided into 3 groups and received 200mg, 300mg and 400mg of Revaprazan. All subjects had an intragastric pH on day 0(baseline), 1 and 7 of each group. On Days 1 and 7, blood samples for determination of plasma Revaprazan concentration were collected into VACUTAINER at pre-dose and at 15, 30, 45min, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24hr post-dose. Helicobacter pylori infection was determined by 13C urea breath test.

Results: The onset of acid suppressing effects was rapid, with day 7 results similar to that of the first day of administration of Revaprazan. The median intragastric pH values on day 1 in 200, 300, and 400mg of Revaprazan groups were 4.3, 4.3, and 4.6, respectively. The median intragastric pH on day 7 in 200, 300, and 400mg groups were 4.4, 4.9, and 5.8, respectively.

Conclusions: Revaprazan showed a rapid onset of action and produced significant inhibition of gastric acid secretion in Helicobacter pylori (+)ve male subjects.