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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01085695

Enrollment

Registered

2010-03-12

Start date

2010-04-30

Completion date

2010-05-31

Last updated

2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Rabeprazole, Japan, healthy Japanese male

Brief summary

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

Detailed 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.

Interventions

DRUGrabeprazole

10 mg normal tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19.

Exclusion criteria

Subjects with allergy

Design outcomes

Primary

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

Secondary

Measure	Time frame
Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring	13 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026