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NCT05699070 Clinical Trial

Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

Drug-drug Interaction Clinical Trial

— DWJ1610  

Official title:
An Open-label Phase 1 Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of DWC202211 and DWC202212 Compared to Coadministration in Healthy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05699070
Other study ID # DW_DWJ1610101
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date February 15, 2023
Est. completion date June 1, 2023

Study information
Verified date January 2023
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 24
Est. completion date June 1, 2023
Est. primary completion date April 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: - Healthy adults aged = 19 and = 50 years at screening - Subjects with a body weight = 50.0 kg to = 90.0 kg with a body mass index (BMI) of = 18.0 kg/m2 to = 27.0 kg/m2 at screening ? BMI (kg/m2) = body weight (kg)/[height (m)]2 - Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information - Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DWC202211 100mg
DWC202211 for 5 days Aspirin 100mg
• DWC202212 5mg
DWC202212 for 3 days Rabeprazole 5mg
• DWC202211 100mg + DWC202212 5mg
DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

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 Cmax up to 27 days
Primary AUClast up to 27 days
Secondary DWC202211 Tmax,ss up to 27 days
Secondary DWC202211 T1/2,ss up to 27 days
Secondary DWC202211 Cmin,ss up to 27 days
Secondary DWC202211 Cavg,ss up to 27 days
Secondary DWC202211 CLss/F up to 27 days
Secondary DWC202211 Vdss/f up to 27 days
Secondary DWC202211 PTF up to 27 days
Secondary DWC202212 Tmax,ss up to 27 days
Secondary DWC202212 T1/2,ss up to 27 days
Secondary DWC202212 Cmin,ss up to 27 days
Secondary DWC202212 Cavg,ss up to 27 days
Secondary DWC202212 CLss/F up to 27 days
Secondary DWC202212 Vdss/f up to 27 days
Secondary DWC202212 PTF up to 27 days
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