A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: rabeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01085708

E3810-J081-034

Details and patient eligibility

About

The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.

Enrollment: 16 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19

Exclusion criteria

Subjects with allergy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole

2

Experimental group

Treatment:

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole

3

Experimental group

Treatment:

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole

4

Active Comparator group

Treatment:

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole

Drug: rabeprazole