Clinical trial: inhibitory effect of revaprazan on gastric acid secretion in healthy male subjects.
OBJECTIVE
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.
Kim
Hyung-Keun
HK
Division of Gastroenterology, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Yeongdeungpo-gu, Seoul.
Park
Soo-Heon
SH
Cheung
Dae-Young
DY
Cho
Young-Seok
YS
Kim
Jin-Il
JI
Kim
Sung-Soo
SS
Chae
Hiun-Suk
HS
Kim
Jae-Kwang
JK
Chung
In-Sik
IS
D000328:Adult; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000378:metabolism; D005500:Follow-Up Studies; D005744:Gastric Acid / Q000378:metabolism*; D005745:Gastric Acidity Determination; D005753:Gastric Mucosa / Q000378:metabolism*; D006801:Humans; D008297:Male; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000378:metabolism; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D012016:Reference Values; D013270:Stomach / Q000187:drug effects
D054328:Proton Pump Inhibitors