Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Drug-drug Interaction

Treatments: Drug: DWP14012 + DWC202005; Drug: DWP14012 + DWC202005, after multiple doses of DWP14012; Drug: DWC202005, alone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04328766

DW_DWP14012106

Details and patient eligibility

About

An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers

Enrollment: 36 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2
• Capable of understanding provided information and complying with protocol requirements
• Provide written informed consent to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 3 patient groups

DWP14012 Cohort A

Experimental group

Treatment:

Drug: DWC202005, alone

DWP14012 Cohort B

Experimental group

Treatment:

Drug: DWP14012 + DWC202005

DWP14012 Cohort C

Experimental group

Treatment:

Drug: DWP14012 + DWC202005, after multiple doses of DWP14012