Trials / Unknown
UnknownNCT05954338
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With Concomitant Multiple Oral Doses of DWC202307 in Healthy Adult Volunteers
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- Sponsor
- Daewoong Pharmaceutical Co. LTD. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.
Detailed description
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DWC202307 | DWC202307 |
| DRUG | DWJ1543 | DWJ1543 |
| DRUG | DWC202216 | DWC202216 |
Timeline
- Start date
- 2023-08-01
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2023-07-20
- Last updated
- 2023-07-24
Source: ClinicalTrials.gov record NCT05954338. Inclusion in this directory is not an endorsement.