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NCT05699070 | Enrolling by invitation | Drug-drug Interaction


Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects
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

Condition or disease

Drug-drug Interaction

Intervention/treatment

DWC202211 100mg

DWC202212 5mg

DWC202211 100mg + DWC202212 5mg

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 24 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : February 15, 2023
Estimated Primary Completion Date : April 24, 2023
Estimated Study Completion Date : June 1, 2023
Arm Intervention/treatment

Experimental: DWC202211

Drug: DWC202211 100mg

Experimental: DWC202212

Drug: DWC202212 5mg

Experimental: DWC202211 + DWC202212

Drug: DWC202211 100mg + DWC202212 5mg

Ages Eligible for Study: 19 Years to 50 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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.

Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

Location Details


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Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Korea, Republic of,

Seoul National University Hospital

Seoul, Korea, Republic of,

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