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
  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:


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
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, see Learn About Clinical Studies.

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
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014