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

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ClinicalTrials.gov Identifier: NCT01202071
Recruitment Status : Completed
First Posted : September 15, 2010
Results First Posted : November 27, 2012
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers
Study Start Date : September 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) [ Time Frame: Day 1 and Day 5 of administration during Period I-IV ]

    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.


  2. 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) ]

    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.




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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01202071     History of Changes
Other Study ID Numbers: E3810-J081-040
First Posted: September 15, 2010    Key Record Dates
Results First Posted: November 27, 2012
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Rabeprazole
proton pump inhibitor
pharmacokinetics
pharmacodynamics
healthy adult male Japanese subjects

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