Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects (DWJ1610)

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Drug-drug Interaction
• Intervention / Treatment: Drug: DWC202211 100mg; Drug: DWC202212 5mg; Drug: DWC202211 100mg + DWC202212 5mg

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWC202211	Drug: DWC202211 100mg; DWC202211 for 5 days Aspirin 100mg
Experimental: DWC202212	Drug: DWC202212 5mg; DWC202212 for 3 days Rabeprazole 5mg
Experimental: DWC202211 + DWC202212	Drug: DWC202211 100mg + DWC202212 5mg; DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax	up to 27 days
AUClast	up to 27 days

Secondary Outcome Measures

Outcome Measure	Time Frame
DWC202211 Tmax,ss	up to 27 days
DWC202211 T1/2,ss	up to 27 days
DWC202211 Cmin,ss	up to 27 days
DWC202211 Cavg,ss	up to 27 days
DWC202211 CLss/F	up to 27 days
DWC202211 Vdss/f	up to 27 days
DWC202211 PTF	up to 27 days
DWC202212 Tmax,ss	up to 27 days
DWC202212 T1/2,ss	up to 27 days
DWC202212 Cmin,ss	up to 27 days
DWC202212 Cavg,ss	up to 27 days
DWC202212 CLss/F	up to 27 days
DWC202212 Vdss/f	up to 27 days
DWC202212 PTF	up to 27 days

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): April 24, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DW_DWJ1610101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No