NCT01085708

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2010

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 13, 2013

Status Verified

September 1, 2010

Enrollment Period

1 month

First QC Date

March 11, 2010

Last Update Submit

May 9, 2013

Conditions

Healthy

Keywords

RabeprazoleJapanhealthy Japanese male

Outcome Measures

Primary Outcomes (1)

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

    One day

Study Arms (4)

1

EXPERIMENTAL
Drug: rabeprazole

2

EXPERIMENTAL
Drug: rabeprazole

3

EXPERIMENTAL
Drug: rabeprazole

4

ACTIVE COMPARATOR
Drug: rabeprazole

Interventions

rabeprazoleDRUG

10 mg normal tablet

1

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19

You may not qualify if:

  • Subjects with allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Kai Shibata

    Clinical Research Center, Eisai, Co., Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2010

First Posted

March 12, 2010

Study Start

April 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 13, 2013

Record last verified: 2010-09