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NCT04819932 Clinical Trial

Pharmacokinetics and Safety of DWJ1451 in Healthy Adults

Healthy Clinical Trial

Official title:
An Open-label, Randomized, 2x2 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1451 and Co-administration of DWC202008 and DWC202009 in Healthy Volunteers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04819932
Other study ID # DW_DWJ1451102
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date March 13, 2021
Est. completion date April 2, 2021

Study information
Verified date January 2021
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Amlodipine, olmesartan, total ezetimibe, rosuvastatin AUCt, Cmax

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 64
Est. completion date April 2, 2021
Est. primary completion date March 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility Inclusion Criteria: - Age 19 to 55 years - Healthy Adult Exclusion Criteria: - Non-Healthy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWJ1451
DWC202008 DWC202009

Locations
Country Name City State
Korea, Republic of Chonbuk National University Hospital Jeonju Jeollabuk-do

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameter of DWJ1451:AUC0-t Area under the plasma xonxentration-time curve from time 0 to t 0 - 72 hours after dosing
Primary Pharmacokinetic parameter of DWJ1451:Cmax Maximum plasma drug concentration 0 - 72 hours after dosing
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