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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01085695
First Posted: March 12, 2010
Last Update Posted: May 13, 2013
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.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  Purpose
The purpose of this study is to assess the pharmacokinetics of rabeprazole under fasting condition.

Condition Intervention Phase
Healthy Drug: rabeprazole Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

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

Enrollment: 16
Study Start Date: April 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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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

  Contacts and Locations
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
  More Information

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01085695     History of Changes
Other Study ID Numbers: E3810-J081-033
First Submitted: March 11, 2010
First Posted: March 12, 2010
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