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

Daewoong Pharmaceutical

Status and phase: Invitation-only; Phase 1

Conditions: Drug-drug Interaction

Treatments: Drug: DWC202212 5mg; Drug: DWC202211 100mg + DWC202212 5mg; Drug: DWC202211 100mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05699070

DW_DWJ1610101

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

DWC202211

Experimental group

Treatment:

Drug: DWC202211 100mg

DWC202212

Experimental group

Treatment:

Drug: DWC202212 5mg

DWC202211 + DWC202212

Experimental group

Treatment:

Drug: DWC202211 100mg + DWC202212 5mg