Status:
COMPLETED
Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04278391
Start Date
July 2 2019
End Date
February 19 2020
Last Update
February 20 2020
Active Locations (1)
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1
Bundang CHA Medical Center
Seongnam-si, Gyeonggi-do, South Korea