Antacids have no influence on the pharmacokinetics of rabeprazole, a new proton pump inhibitor, in healthy volunteers.
OBJECTIVE
This randomized, open-label, crossover study was conducted to evaluate the effect of a single dose of antacid, aluminum and magnesium hydroxide suspension, on pharmacokinetics of rabeprazole in healthy male volunteers.


METHODS
Twelve subjects were randomly divided into 6 groups of 2 subjects each, and received 20 mg of rabeprazole either without antacid, concomitantly with antacid, or one hour after administration of antacid in three experimental arms with washout period of one week. The concentrations of rabeprazole in plasma were determined by high performance liquid chromatography.


RESULTS
Rabeprazole was well tolerated at the 20 mg dose level when given with or without antacid. The pharmacokinetic parameters, Cmax, t(max), AUC and t1/2, showed no statistically significant differences when rabeprazole was administered alone, concomitantly with antacid or one hour after antacid administration.


CONCLUSIONS
No influence of single dose of antacid on pharmacokinetics of rabeprazole was observed.
Yasuda
S
S
Clinical Research Department, Clinical Research Center, Eisai Co., Ltd., Tokyo, Japan.
Higashi
S
S
Murakami
M
M
Tomono
Y
Y
Kawaguchi
M
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000863:Antacids / Q000494:pharmacology*; D000897:Anti-Ulcer Agents / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001562:Benzimidazoles / Q000097:blood / Q000493:pharmacokinetics*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D004347:Drug Interactions; D006207:Half-Life; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000031:analogs & derivatives; D006180:Proton-Translocating ATPases / Q000037:antagonists & inhibitors*; D064750:Rabeprazole
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000863:Antacids; D000897:Anti-Ulcer Agents; D001562:Benzimidazoles; D064750:Rabeprazole; D006180:Proton-Translocating ATPases; D009853:Omeprazole