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

A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02214693

Enrollment

Registered

2014-08-12

Start date

2014-07-31

Completion date

Unknown

Last updated

2015-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

Keywords

patients

Brief summary

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

Interventions

DRUGDA-1229

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Area Under Curve(AUC) last	Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026