A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)

NCT01202071 ↗

Phase 2 Completed 24 enrolled Eisai Inc.

RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.

Timeline

Start: 2010-09
Primary completion: 2010-12
Completion: 2010-12

Publications

Hayato S, Hasegawa S, Hojo S, Okawa H, Abe H, Sugisaki N, Munesue M, Horai Y, Ohnishi A. Dose-response relationships of rabeprazole 5, 10, 20, and 40 mg once daily on suppression of gastric acid secretion through the night in healthy Japanese individuals with different CYP2C19 genotypes. Eur J Clin Pharmacol. 2012 May;68(5):579-88. doi: 10.1007/s00228-011-1164-7. Epub 2011 Nov 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rabeprazole	Small molecule	5 mg	Oral
Subject	Rabeprazole	Small molecule	10 mg	Oral
Subject	Rabeprazole	Small molecule	20 mg	Oral
Subject	Rabeprazole	Small molecule	40 mg	Oral

Indications

No indication recorded.