NCT02004327

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

Randomized, Open-label, Single Dose, Crossover Phase I Clinical Study to Evaluate the Pharmacokinetics of DW1029M 300 mg, 600 mg and 1200 mg After Oral Administration in Healthy Male Volunteer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Dong Wha Pharmaceutical Co. Ltd. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d \~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed. Through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order . The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk National University Hospital, convened as a physical examination and perform hwalryeong signs . One person to dinner , except for the drinking water should be fasting . One clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication . The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before swallowing drugs should . Blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. The subjects that had a fixed schedule and is discharged on the morning of the second . Is at least one week washout period . Since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed. After a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	DW1029M300mg	DW1029M300mg PO Once
DRUG	DW1029M600mg	DW1029M300mg 2 tablets Once
DRUG	DW1029M1200mg	DW1029M300mg 4 tablets PO Once

Timeline

• Start date: 2013-12-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2013-12-09
• Last updated: 2015-06-29

Locations

1 site across 1 country: South Korea