ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01085695
Recruitment Status : Completed
First Posted : March 12, 2010
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Healthy Drug: rabeprazole Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Fasting Condition)
Study Start Date : April 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 Drug: rabeprazole
10 mg normal tablet

Experimental: 2 Drug: rabeprazole
Type 1 granule containing rabeprazole 10 mg

Experimental: 3 Drug: rabeprazole
Type 2 granule containing rabeprazole 10 mg

Active Comparator: 4 Drug: rabeprazole
Type 3 granule containing rabeprazole 10 mg




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring [ Time Frame: 13 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19.

Exclusion criteria:

Subjects with allergy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085695


Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Kai Shibata Clinical Research Center, Eisai, Co., Ltd

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01085695     History of Changes
Other Study ID Numbers: E3810-J081-033
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: September 2010

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Rabeprazole
Japan
healthy Japanese male

Additional relevant MeSH terms:
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action