Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers
Phase 1
Not yet recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05954338
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.
- Detailed Description
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Over 19 year old
- Healthy adult volunteer
Exclusion Criteria
- Eye disorders including cataracts
- Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention: DWC202307 + DWJ1543 DWC202307 - Intervention: DWC202307 + DWJ1543 DWJ1543 - Intervention: DWC202307 + DWC202216 DWC202307 - Intervention: DWC202307 + DWC202216 DWC202216 -
- Primary Outcome Measures
Name Time Method Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543 At pre-dose (0 hour), and post-dose 1 to 120 hour. Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543 At pre-dose (0 hour), and post-dose 1 to 120 hour.
- Secondary Outcome Measures
Name Time Method