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

NCT01202071 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-11-30

Study results available
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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.

Conditions

  • Healthy

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Masahiro Munesue · Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Japan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202071 on ClinicalTrials.gov