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

NCT ID: NCT01202071

Last Updated: 2012-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Rabeprazole proton pump inhibitor pharmacokinetics pharmacodynamics healthy adult male Japanese subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rabeprazole sodium Tablets, 5 mg

Group Type EXPERIMENTAL

Rabeprazole sodium, 5 mg Tablets

Intervention Type 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.

Rabeprazole sodium Tablets, 10 mg

Group Type EXPERIMENTAL

Rabeprazole sodium, 10 mg Tablets

Intervention Type 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.

Rabeprazole sodium Tablets, 20 mg

Group Type EXPERIMENTAL

Rabeprazole sodium, 20 mg Tablets

Intervention Type 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.

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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E3810, E3810-J081-040 E3810, E3810-J081-040 E3810, E3810-J081-040 E3810, E3810-J081-040

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Masahiro Munesue

Role: STUDY_DIRECTOR

Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section

Locations

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Toshima-ku, Tokyo, Japan

Site Status

Countries

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Japan

References

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Hayato S, Hasegawa S, Hojo S, Okawa H, Abe H, Sugisaki N, Munesue M, Horai Y, Ohnishi A. Dose-response relationships of rabeprazole 5, 10, 20, and 40 mg once daily on suppression of gastric acid secretion through the night in healthy Japanese individuals with different CYP2C19 genotypes. Eur J Clin Pharmacol. 2012 May;68(5):579-88. doi: 10.1007/s00228-011-1164-7. Epub 2011 Nov 23.

Reference Type DERIVED
PMID: 22108775 (View on PubMed)

Other Identifiers

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E3810-J081-040

Identifier Type: -

Identifier Source: org_study_id