Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 52
- Primary Endpoint
- The maximum serum concentration(Cmax) of DWJ1589 and DWC202315
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Sequence A: RTRT
T: DWJ1589 R: DWC202315
Intervention: Period 4 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
Intervention: Period 1 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
Intervention: Period 2 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
Intervention: Period 3 (Drug)
Sequence B: TRTR
T: DWJ1589 R: DWC202315
Intervention: Period 4 (Drug)
Sequence A: RTRT
T: DWJ1589 R: DWC202315
Intervention: Period 2 (Drug)
Sequence A: RTRT
T: DWJ1589 R: DWC202315
Intervention: Period 3 (Drug)
Sequence A: RTRT
T: DWJ1589 R: DWC202315
Intervention: Period 1 (Drug)
Outcomes
Primary Outcomes
The maximum serum concentration(Cmax) of DWJ1589 and DWC202315
Time Frame: 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
Time Frame: At pre-dose (0 hour), and post-dose 0.83 to 72 hour.
AUClast of DWJ1589 and DWC202315
Secondary Outcomes
No secondary outcomes reported