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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Co., Ltd.
• Treatments: Rabeprazole

Criteria

Inclusion Criteria:

• healthy adult Japanese male between the age of 20-40

• body mass index between 18.5-25

Exclusion Criteria:

• clinically significant abnormal physical examination, vital signs or electrocardiogram

• use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks

• use of any non-prescription medication within the previous 1 week

• history of drug or alcohol abuse