drugset / Trial / NCT02004327

The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer

NCT02004327

Phase 1 Completed 6 enrolled Dong Wha Pharmaceutical Co. Ltd.
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

EvaluationDrugModalityDoseRoute
Subject DW1029M Unknown 300 mg Oral
Subject DW1029M Unknown 600 mg Oral
Subject DW1029M Unknown 1200 mg Oral