drugset / Trial / NCT02004327
The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
RandomizedCrossoverOpen-labelBasic science
Summary
1. Objective After single dose in healthy adults the capacity of the Group for DW1029M evaluate the pharmacokinetic characteristics. 2. Indication Diabetic kidney disease 3. Efficacy 1. Primary * AUClast, AUCinf, AUClast/D, AUCinf/D * Cmax, Cmax/D 2. Secondary * Tmax, t1/2, CL/F, Vz/F 4. Safety 1. Adverse Event Monitoring 2. V/S, EKG, Laboratory Test, P/E
Timeline
- Start
- 2013-12
- Primary completion
- 2013-12
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DW1029M | Unknown | 300 mg | Oral |
| Subject | DW1029M | Unknown | 600 mg | Oral |
| Subject | DW1029M | Unknown | 1200 mg | Oral |