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Pharmacodynamic and Pharmacokinetic Study of E3710 Following Oral Administration to Healthy, Male, Japanese Subjects

NCT01390714 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-14

No results posted yet for this study

Summary

The purpose of this study is to investigate the pharmacodynamics (PD) and pharmacokinetics of E3710 following oral administration to Healthy Male Japanese Subjects

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

E3710

Arm A: 1. E3710 40 mg→RPZ 10 mg→E3710 20 mg 2. RPZ 10 mg→E3710 20 mg→E3710 40 mg 3. E3710 20 mg→E3710 40 mg→RPZ 10 mg Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration.

DRUG

E3710

Arm B: 1. E3710 40 mg→E3710 80 mg→EPZ 40 mg 2. E3710 80 mg→EPZ 40 mg →E3710 40 mg 3. EPZ 40 mg→E3710 40 mg→E3710 80 mg Crossover study of E3710 40 mg, E3710 80 mg, and EPZ 40 mg, once daily, for 5 days, oral administration.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mark Yen · California Clinical Trials

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
2011-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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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 NCT01390714 on ClinicalTrials.gov