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Food-Effect on PK and PD of Single Oral Dose of CJ-12420 in Healthy Male Subjects

NCT01830309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-04-12

No results posted yet for this study

Summary

* Primary: To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of CJ-12420 in healthy male subjects.
* Secondary

* To explore food effect on the pharmacodynamics (PD) of single oral dose of CJ-12420 in healthy male subjects(PD/PK group)
* To evaluate the safety of single oral dose of CJ-12420 in healthy male subjects under fed or fasting condition.

Conditions

  • Healthy

Interventions

DRUG

CJ-12420 200mg

Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition

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
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

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 NCT01830309 on ClinicalTrials.gov