A Randomized, Open Label, Single Dose, Crossover Study to Compare the Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers

Daewoong Pharmaceutical Co. LTD.1 site in 1 country40 target enrollmentJuly 2, 2019

ConditionsHealthy

InterventionsDWC201903 DWJ1421

DrugsDWJ1421 DWC201903

Overview

Phase: Phase 1
Intervention: DWC201903
Conditions: Healthy
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 40
Locations: 1
Primary Endpoint: Cmax
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.

Registry

clinicaltrials.gov

Start Date

July 2, 2019

End Date

February 19, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Between 19 aged and 45 aged in healthy male adult
•Body weight more than 50kg
•Body Mass Index more than 18.0 and under 27.0

Exclusion Criteria

•Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history
•Those who have a gastrointestinal disease history that can effect drug absorption or surgery
•Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product