PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients

Dong-A ST

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: DA-1229

Study type: Interventional

Funder types: Industry

Identifiers

NCT02214693

DA1229_RI_I

Details and patient eligibility

About

This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.

Enrollment: 30 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 4 patient groups

Group 1(Severe decrease in GFR)

Experimental group

Description:

Severe decrease in GFR

Treatment:

Drug: DA-1229

Group 2(Moderate decrease in GFR)

Experimental group

Description:

Moderate decrease in GFR

Treatment:

Drug: DA-1229

Group 3(Mild decrease in GFR)

Experimental group

Description:

Mild decrease in GFR

Treatment:

Drug: DA-1229

Group 4(Normal GFR)

Experimental group

Description:

Normal GFR

Treatment:

Drug: DA-1229