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
• Status: Enrolling by invitation
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Drug-drug Interaction

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