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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01085708
First received: March 11, 2010
Last updated: May 9, 2013
Last verified: September 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: rabeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085708

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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01085708     History of Changes
Other Study ID Numbers: E3810-J081-034
Study First Received: March 11, 2010
Last Updated: May 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Rabeprazole
Japan
healthy Japanese male

Additional relevant MeSH terms:
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014