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

May 9, 2013 updated by: Eisai Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Healthy

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Male

Description

Inclusion criteria:

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19

Exclusion criteria:

Subjects with allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: rabeprazole 10 mg normal tablet Drug: rabeprazole Type 1 granule containing rabeprazole 10 mg Drug: rabeprazole Type 2 granules containing rabeprazole 10 mg Drug: rabeprazole Type 3 granules containing rabeprazole 10 mg
Experimental: 2	Drug: rabeprazole 10 mg normal tablet Drug: rabeprazole Type 1 granule containing rabeprazole 10 mg Drug: rabeprazole Type 2 granules containing rabeprazole 10 mg Drug: rabeprazole Type 3 granules containing rabeprazole 10 mg
Experimental: 3	Drug: rabeprazole 10 mg normal tablet Drug: rabeprazole Type 1 granule containing rabeprazole 10 mg Drug: rabeprazole Type 2 granules containing rabeprazole 10 mg Drug: rabeprazole Type 3 granules containing rabeprazole 10 mg
Active Comparator: 4	Drug: rabeprazole 10 mg normal tablet Drug: rabeprazole Type 1 granule containing rabeprazole 10 mg Drug: rabeprazole Type 2 granules containing rabeprazole 10 mg Drug: rabeprazole Type 3 granules containing rabeprazole 10 mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

Study Director: Kai Shibata, Clinical Research Center, Eisai, Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

March 11, 2010

First Submitted That Met QC Criteria

March 11, 2010

First Posted (Estimate)

March 12, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

E3810-J081-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Prevent Age Resort "Pervaya Liniya"

Recruiting

First Line Prevent Age Study (FLIPS)

Healthy Aging | Healthy Diet | Healthy Lifestyle

Russian Federation
Maastricht University Medical Center

Completed

Reference Gait Data for Healthy Subjects

Healthy Volunteers | Healthy Subjects | Healthy Adults

Netherlands
Yale University

Not yet recruiting

Health-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For Health

Healthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol

United States
Hasselt University

Recruiting

Cause-effect Relationships Between Brain Networks and Bimanual Coordination in Older Adults

Healthy | Healthy Aging

Belgium
Galera Therapeutics, Inc.
Syneos Health

Completed

A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
Galera Therapeutics, Inc.
Syneos Health

Completed

A Phase 1, Randomized, Placebo-and Positive-Controlled Crossover Study to Determine the Effect of Single-Dose GC4419 on QTc Interval in Healthy Volunteers

Healthy | Healthy Volunteers

Australia
University of Pennsylvania

Active, not recruiting

The Physiological Chronobiome Modified by Age, Sex and Under Evoked Conditions

Healthy | Healthy Aging

United States
Chalmers University of Technology
Göteborg University

Completed

Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein

Healthy | Nutrition, Healthy

Sweden
Lancaster University

Recruiting

Speed of Absorption

Healthy | Nutrition, Healthy

United Kingdom
University of Manitoba

Not yet recruiting

A Multidisciplinary Investigation of Cardiovascular Benefits of Wild Rice

Healthy | Healthy Diet

Clinical Trials on rabeprazole

Johnson & Johnson Pharmaceutical Research & Development...

Completed

A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers

Healthy
Johnson & Johnson Pharmaceutical Research & Development...

Completed

A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers

Healthy
Eisai Inc.

Completed

Maintenance Intermittent Therapy for Symptomatic GERD Patients

Gastroesophageal Reflux Disease

United States
Inje University

Withdrawn

Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD (DRNERD)

Gastroesophageal Reflux Disease

Korea, Republic of
The Catholic University of Korea
Janssen Korea, Ltd., Korea

Completed

Effects of Oral Rabeprazole on the Prevention of Ulcer Bleeding Following Endoscopic Mucosal Resection

Early Gastric Adenocarcinoma | Adenocarcinoma, Tubular

Korea, Republic of
Janssen Research & Development, LLC
Eisai Inc.

Completed

A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive

Gastroesophageal Reflux Disease (GERD)

United States, Poland, United Kingdom, Belgium, Brazil
Yungjin Pharm. Co., Ltd.
Seoul National University Hospital

Completed

A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

Gastroesophageal Reflux Disease

Korea, Republic of
Seoul National University Hospital
IlDong Pharmaceutical Co Ltd

Completed

Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.

Esophageal Disease

Korea, Republic of
Eisai Co., Ltd.

Completed

A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)

Healthy

Japan
Eisai Inc.

Completed

Comparing the Efficacy, Safety, and Tolerability of Rabeprazole ER 50 mg With Placebo in Subjects With Symptomatic Gastroesophageal Reflux Disease (sGERD)

Symptomatic Gastroesophageal Reflux Disease (sGERD)

United States

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Healthy

Clinical Trials on rabeprazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations