Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1567 in Healthy Adult Volunteers
- Registration Number
- NCT06109259
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
This study aims to compare the pharmacokinetics and safety following administration of DWJ1567 and DWC202312 in healthy volunteers
- Detailed Description
The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1567 and DWC202312. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1567 and DWC202312.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
- Over 19 year old
Exclusion Criteria
- Galactose intolerance
- Lapp lactase deficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DWC202312 DWC202312 DWC202312 DWJ1567 DWJ1567 DWJ1567
- Primary Outcome Measures
Name Time Method Cmax,ss of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour. AUCt of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour.
- Secondary Outcome Measures
Name Time Method AUCt/AUCinf of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour AUCinf of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour Tmax of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour t1/2 of DWJ1567 and DWC202312 At pre-dose (0 hour), and post-dose 0 to 72 hour
Trial Locations
- Locations (1)
H Plus YANGJI Hospital
🇰🇷Seoul, Korea, Republic of