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NCT Number: NCT01202071

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

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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Toshima-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabeprazole sodium, 5 mg Tablets

Drug

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 names: E3810, E3810-J081-040

Rabeprazole sodium, 10 mg Tablets

Drug

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 names: E3810, E3810-J081-040

Rabeprazole sodium, 20 mg Tablets

Drug

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 names: E3810, E3810-J081-040

Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)

Drug

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 names: E3810, E3810-J081-040

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 15, 2010
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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