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

Eisai Co., Ltd.16 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

rabeprazoleDRUG

10 mg normal tablet

rabeprazoleDRUG

Type 1 granule containing rabeprazole 10 mg

rabeprazoleDRUG

Type 2 granule containing rabeprazole 10 mg

rabeprazole

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19. Exclusion criteria: Subjects with allergy

Outcomes

Primary Outcomes

The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC)

Time frame: One day

Secondary Outcomes

Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring

Time frame: 13 days

Data from ClinicalTrials.gov

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