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

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:

Drug Information available for: Rabeprazole Rabeprazole sodium

U.S. FDA Resources

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

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):

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. Epub 2011 Nov 23.

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 May 23, 2013