Healthy Subjects
Conditions
Brief summary
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
Detailed description
This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and safety of DWJ1511 and DWC202501. in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.
Interventions
DRUGDWJ1511
Test drug: DWJ1511
DRUGDWC202501
Comparator: DWC202501
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female participants aged ≥19 years and \<65 years at the time of screening * Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²)
Exclusion criteria
* Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration. * Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration. * Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | 0-12 Hours | Area under the plasma drug concentration-time curve \[AUCt\] of DWJ1511 and DWC202501 |
| Maximum plasma concentration [Cmax] | 0-12 Hours | Maximum plasma concentration \[Cmax\] of DWJ1511 and DWC202501 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] | 0-12 Hours | Area under the plasma drug concentration-time curve from time 0 to infinity \[AUCinf\] of DWJ1511 and DWC202501 |
Countries
South Korea
Contacts
Primary ContactKang
Outcome results
None listed