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Completed

NCT Number: NCT02214693

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

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Center, Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-1229

Drug

Other names: Evogliptin

Primary outcomes

  1. Area Under Curve(AUC) last

    Time frame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
First posted
Aug 12, 2014
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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