A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 healthy
Started Sep 2010
Shorter than P25 for phase_2 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 14, 2010
CompletedFirst Posted
Study publicly available on registry
September 15, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
November 27, 2012
CompletedNovember 30, 2012
November 1, 2012
3 months
September 14, 2010
October 26, 2012
November 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration
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.
Day 5 of administration during Period I-IV
Secondary Outcomes (2)
Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax)
Day 1 and Day 5 of administration during Period I-IV
Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t])
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)
Study Arms (4)
Rabeprazole sodium Tablets, 5 mg
EXPERIMENTALRabeprazole sodium Tablets, 10 mg
EXPERIMENTALRabeprazole sodium Tablets, 20 mg
EXPERIMENTALRabeprazole sodium Tablets, 40 mg (two 20 mg Tablets)
EXPERIMENTALInterventions
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 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 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) 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.
Eligibility Criteria
You may qualify if:
- healthy adult Japanese male between the age of 20-40
- body mass index between 18.5-25
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (1)
Unknown Facility
Toshima-ku, Tokyo, Japan
Related Publications (1)
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.
PMID: 22108775DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Masaharu Yokoyama, Director
- Organization
- Eisai Co., Ltd.
Study Officials
- STUDY DIRECTOR
Masahiro Munesue
Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2010
First Posted
September 15, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 30, 2012
Results First Posted
November 27, 2012
Record last verified: 2012-11