A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01202071
First received: September 14, 2010
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.


Condition Intervention Phase
Healthy
Drug: Rabeprazole sodium, 5 mg Tablets
Drug: Rabeprazole sodium, 10 mg Tablets
Drug: Rabeprazole sodium, 20 mg Tablets
Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration [ Time Frame: Day 5 of administration during Period I-IV ] [ Designated as safety issue: No ]
    The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.


Secondary Outcome Measures:
  • Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) [ Time Frame: Day 1 and Day 5 of administration during Period I-IV ] [ Designated as safety issue: No ]

    Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).

    Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.


  • Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t]) [ Time Frame: Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose) ] [ Designated as safety issue: No ]

    Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV).

    Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity.



Enrollment: 24
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rabeprazole sodium Tablets, 5 mg Drug: Rabeprazole sodium, 5 mg Tablets

Rabeprazole sodium Tablets, 5 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.

Other Name: E3810, E3810-J081-040
Experimental: Rabeprazole sodium Tablets, 10 mg Drug: Rabeprazole sodium, 10 mg Tablets

Rabeprazole sodium Tablets, 10 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.

Other Name: E3810, E3810-J081-040
Experimental: Rabeprazole sodium Tablets, 20 mg Drug: Rabeprazole sodium, 20 mg Tablets

Rabeprazole sodium Tablets, 20 mg administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast.

Other Name: E3810, E3810-J081-040
Experimental: Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) Drug: Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)

Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days.

Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.

Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast.

Other Name: E3810, E3810-J081-040

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adult Japanese male between the age of 20-40
  • body mass index between 18.5-25

Exclusion Criteria:

  • clinically significant abnormal physical examination, vital signs or electrocardiogram
  • use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
  • use of any non-prescription medication within the previous 1 week
  • history of drug or alcohol abuse
  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: NCT01202071

Locations
Japan
Toshima-ku, Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Masahiro Munesue Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01202071     History of Changes
Other Study ID Numbers: E3810-J081-040
Study First Received: September 14, 2010
Results First Received: October 26, 2012
Last Updated: November 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Rabeprazole
proton pump inhibitor
pharmacokinetics
pharmacodynamics
healthy adult male Japanese subjects

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

ClinicalTrials.gov processed this record on July 20, 2014