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

Eisai

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Rabeprazole sodium, 20 mg Tablets; Drug: Rabeprazole sodium, 10 mg Tablets; Drug: Rabeprazole sodium, 5 mg Tablets; Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202071

E3810-J081-040

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Rabeprazole sodium Tablets, 5 mg

Experimental group

Treatment:

Drug: Rabeprazole sodium, 5 mg Tablets

Rabeprazole sodium Tablets, 10 mg

Experimental group

Treatment:

Drug: Rabeprazole sodium, 10 mg Tablets

Rabeprazole sodium Tablets, 20 mg

Experimental group

Treatment:

Drug: Rabeprazole sodium, 20 mg Tablets

Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets)

Experimental group

Treatment:

Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)