Trials / Unknown
UnknownNCT05954247
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers Under Fasting Conditions
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (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 pharmacokinetic characteristics after administration of DWJ1543 in healty 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 | 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 NCT05954247. Inclusion in this directory is not an endorsement.