Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: DWC201903; Drug: DWJ1421

• 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

Study Timeline

• Study Start: 2019-07-02
• Primary Completion: 2019-08-10
• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study Completion: 2020-02-19
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20

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

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of