Pharmacokinetics and Safety of DWJ1451 in Healthy Adults

Phase 1

• Conditions: Healthy
• Interventions: Drug: DWJ1451

• Registration Number: NCT04819932
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-27
• Study Start: 2021-03-13
• Primary Completion: 2021-03-13
• Study First Submitted QC: 2021-03-25
• Last Update Submitted: 2021-03-25
• Study First Posted: 2021-03-29
• Last Update Posted: 2021-03-29
• Study Completion: 2021-04-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age 19 to 55 years
• Healthy Adult

Exclusion Criteria

• Non-Healthy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group1	DWJ1451	subject take DWC202008 and DWC2020091 on a fasted condition, and after wash out period, take DWJ1451 with on a fasted condition
group2	DWJ1451	subject take DWJ1451 on a fasted condition, and after wash out period, take DWC202008 and DWC202009 with on a fasted condition

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameter of DWJ1451:AUC0-t	0 - 72 hours after dosing	Area under the plasma xonxentration-time curve from time 0 to t
Pharmacokinetic parameter of DWJ1451:Cmax	0 - 72 hours after dosing	Maximum plasma drug concentration

Trial Locations

Locations (1)

Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of