Study of E3810 for Healthy Japanese Male (Under Fasting Condition)

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: rabeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01085695

E3810-J081-033

Details and patient eligibility

About

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

Full description

The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulation: normal 10 mg rabeprazole tablet rabeprazole, and Type 1, Type 2, and Type 3 granule formulation containing rabeprazole 10 mg.

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)

---

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