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

NCT ID: NCT02214693

Last Updated: 2015-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Brief Summary

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

Detailed Description

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Conditions

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Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group 1(Severe decrease in GFR)

Severe decrease in GFR

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

Group 2(Moderate decrease in GFR)

Moderate decrease in GFR

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

Group 3(Mild decrease in GFR)

Mild decrease in GFR

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

Group 4(Normal GFR)

Normal GFR

Group Type EXPERIMENTAL

DA-1229

Intervention Type DRUG

Interventions

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DA-1229

Intervention Type DRUG

Other Intervention Names

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Evogliptin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trial Center, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA1229_RI_I

Identifier Type: -

Identifier Source: org_study_id

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