Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers

Daewoong Pharmaceutical Co. LTD.36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug-drug Interaction

Interventions

DWC202005, aloneDRUG

DWC202005, as a single dose

DWP14012 + DWC202005DRUG

DWP14012 and DWC202005, as a single dose

DWP14012 + DWC202005, after multiple doses of DWP14012DRUG

DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Nucleus Network (QPharm)

Queensland, Queensland, Australia

Outcomes

Primary Outcomes

Area under the plasma drug concentration-time curve

AUClast of DWC202005

Time frame: upto 48 hours postdose

Peak Plasma Concentration (Cmax)

Cmax of DWC202005

Time frame: upto 48 hours postdose

Incidence of Treatment-Emergent Adverse Events

Time frame: up to 19 days

Data from ClinicalTrials.gov

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