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

Phase 1CompletedNCT01085708

Eisai Co., Ltd.16 enrolled

Overview

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

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 granules 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

Data from ClinicalTrials.gov

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