Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

Phase 1

• Conditions: Drug-drug Interaction
• Interventions: Drug: DWC202212 5mg; Drug: DWC202211 100mg + DWC202212 5mg; Drug: DWC202211 100mg

• Registration Number: NCT05699070
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-26
• Study Start: 2023-02-15
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-04
• Primary Completion: 2023-04-24
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 24

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
DWC202212	DWC202212 5mg	-
DWC202211 + DWC202212	DWC202211 100mg + DWC202212 5mg	-
DWC202211	DWC202211 100mg	-

Primary Outcome Measures

Name	Time	Method
Cmax	up to 27 days
AUClast	up to 27 days

Secondary Outcome Measures

Name	Time	Method
DWC202211 Tmax,ss	up to 27 days
DWC202211 Cmin,ss	up to 27 days
DWC202211 T1/2,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
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of