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A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers

NCT01925313 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-08-19

No results posted yet for this study

Summary

Study objectives

* To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers.
* To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers.

Conditions

  • Healthy

Interventions

DRUG

CJ-30044

20.51mg a day,PO,QD

DRUG

TALION TAB. 10mg

10mg a day,PO,BID

Sponsors & Collaborators

  • HK inno.N Corporation

    lead INDUSTRY

Principal Investigators

  • Min-Su Park, PhD · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-02-28
Completion
2013-05-31

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 NCT01925313 on ClinicalTrials.gov