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Safety, Tolerability, PK, PD of Escalating Single and Multiple Oral Doses of CJ-12420 in Healthy Male Subjects

NCT01473173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2013-04-10

No results posted yet for this study

Summary

The objectives of this study are:

* To evaluate the safety and tolerability of single and multiple oral doses of CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PK of orally administered CJ-12420 in healthy male subjects.
* To evaluate the single- and multiple-dose PD of orally administered CJ-12420 in healthy male subjects.
* To compare the multiple-dose pharmacodynamics (PD) of orally administered CJ-12420 and esomeprazole in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

CJ-12420

DRUG

Esomeprazole 40mg

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Kyun-Seop Bae, MD, Ph.D · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • South Korea

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 NCT01473173 on ClinicalTrials.gov