Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315
Phase 1
Not yet recruiting
- Conditions
- Healthy Volunteers
- Interventions
- Drug: Period 1Drug: Period 2Drug: Period 3Drug: Period 4
- Registration Number
- NCT06592495
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1589 and DWC202315 in healty adult volunteers.
- Detailed Description
The study design is a Randomized, Open-label, Oral, Single-dose, 2 × 4 crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWJ1589 and DWC202315. Secondary endpoints were AUCinf, AUClast/AUCinf, Tmax and t1/2 of DWJ1589 and DWC202315.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Over 19 year old
- Healthy adult volunteers
Exclusion Criteria
- with a history of mental disorder
- For female volunteers, those who are suspected of being pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A: RTRT Period 1 T: DWJ1589 R: DWC202315 Sequence A: RTRT Period 2 T: DWJ1589 R: DWC202315 Sequence A: RTRT Period 3 T: DWJ1589 R: DWC202315 Sequence A: RTRT Period 4 T: DWJ1589 R: DWC202315 Sequence B: TRTR Period 1 T: DWJ1589 R: DWC202315 Sequence B: TRTR Period 2 T: DWJ1589 R: DWC202315 Sequence B: TRTR Period 3 T: DWJ1589 R: DWC202315 Sequence B: TRTR Period 4 T: DWJ1589 R: DWC202315
- Primary Outcome Measures
Name Time Method The maximum serum concentration(Cmax) of DWJ1589 and DWC202315 At pre-dose (0 hour), and post-dose 0.83 to 72 hour. Cmax of DWJ1589 and DWC202315
The Area under the curve(AUC)last of DWJ1589 and DWC202315 At pre-dose (0 hour), and post-dose 0.83 to 72 hour. AUClast of DWJ1589 and DWC202315
- Secondary Outcome Measures
Name Time Method