NCT05699070
Enrolling By Invitation
Phase 1
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
Daewoong Pharmaceutical Co. LTD.1 site in 1 country24 target enrollmentFebruary 15, 2023
ConditionsDrug-drug Interaction
Overview
- Phase
- Phase 1
- Intervention
- DWC202211 100mg
- Conditions
- Drug-drug Interaction
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Cmax
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
DWC202211
Intervention: DWC202211 100mg
DWC202212
Intervention: DWC202212 5mg
DWC202211 + DWC202212
Intervention: DWC202211 100mg + DWC202212 5mg
Outcomes
Primary Outcomes
Cmax
Time Frame: up to 27 days
AUClast
Time Frame: up to 27 days
Secondary Outcomes
- 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 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)
- 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)
Study Sites (1)
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