Status:
COMPLETED
PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Renal Impairment
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.
Eligibility Criteria
Inclusion
- Age between 20 and 70
- Weights between 50 and 90kg(Female : 40 and 90kg)
- Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
- Stable results of estimated GFR in 4 months recently
Exclusion
- Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
- Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
- Volunteer who already participated in other trials in 2 months
- Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02214693
Start Date
July 1 2014
Last Update
August 27 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Trial Center, Seoul National University Hospital
Seoul, South Korea