PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients
- Registration Number
- NCT02214693
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4(Normal GFR) DA-1229 Normal GFR Group 3(Mild decrease in GFR) DA-1229 Mild decrease in GFR Group 1(Severe decrease in GFR) DA-1229 Severe decrease in GFR Group 2(Moderate decrease in GFR) DA-1229 Moderate decrease in GFR
- Primary Outcome Measures
Name Time Method Area Under Curve(AUC) last Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trial Center, Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of