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A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial 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: NCT01085708
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. )

Tracking Information
First Submitted Date  ICMJE March 11, 2010
First Posted Date  ICMJE March 12, 2010
Last Update Posted Date May 13, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
The following pharmacokinetic parameters are calculated: maximum drug concentration (Cmax) in plasma; area under the plasma concentration time curve (AUC) [ Time Frame: One day ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01085708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2010)
Vital signs, clinical laboratory screens of blood and urine, adverse event monitoring, adverse drug reaction monitoring [ Time Frame: 13 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
Official Title  ICMJE A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)
Brief Summary The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: rabeprazole
    10 mg normal tablet
  • Drug: rabeprazole
    Type 1 granule containing rabeprazole 10 mg
  • Drug: rabeprazole
    Type 2 granules containing rabeprazole 10 mg
  • Drug: rabeprazole
    Type 3 granules containing rabeprazole 10 mg
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: rabeprazole
  • Experimental: 2
    Intervention: Drug: rabeprazole
  • Experimental: 3
    Intervention: Drug: rabeprazole
  • Active Comparator: 4
    Intervention: Drug: rabeprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2010)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

Subjects with homozygous or heterozygous extensive metabolizers of cytochrome P4502C19

Exclusion criteria:

Subjects with allergy

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085708
Other Study ID Numbers  ICMJE E3810-J081-034
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc. ( Eisai Co., Ltd. )
Study Sponsor  ICMJE Eisai Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kai Shibata Clinical Research Center, Eisai, Co., Ltd
PRS Account Eisai Inc.
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP