Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers
- Registration Number
- NCT04278391
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A (RT) DWC201903 Period 1 : Reference drug (DWC201903) Period 2 : Test durg(DWJ1421) B (TR) DWJ1421 Period 1 : Test durg(DWJ1421) Period 2 : Reference drug (DWC201903)
- Primary Outcome Measures
Name Time Method Cmax 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h Maximum concentration of DWJ1421
AUClast 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h Area under the drug concentration-time curve
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bundang CHA Medical Center
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of