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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01085695
First received: March 11, 2010
Last updated: May 9, 2013
Last verified: September 2010
History of Changes
  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
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 Fasting Condition)

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring [ Time Frame: 13 days ] [ Designated as safety issue: Yes ]

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

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: NCT01085695

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: NCT01085695     History of Changes
Other Study ID Numbers: E3810-J081-033
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 May 19, 2013