Trials / Not Yet Recruiting
Not Yet RecruitingNCT06592495
Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315
Bioepuivalence Study for the Safety and the Pharmacokinetics of DWJ1589 and DWC202315 in Healthy Adult Volunteers Under Fasting Conditions
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- Daewoong Pharmaceutical Co. LTD. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Period 1 | DWJ1589 or DWC202315 |
| DRUG | Period 2 | DWJ1589 or DWC202315 |
| DRUG | Period 3 | DWJ1589 or DWC202315 |
| DRUG | Period 4 | DWJ1589 or DWC202315 |
Timeline
- Start date
- 2024-10-01
- Primary completion
- 2025-01-01
- Completion
- 2025-10-01
- First posted
- 2024-09-19
- Last updated
- 2024-09-23
Source: ClinicalTrials.gov record NCT06592495. Inclusion in this directory is not an endorsement.