Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT02754219
Phase
PHASE1
Status
Completed

Conditions

  • Liver Dysfunction

Eligibility Criteria

Sex
ALL
Age
19 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin

Key Dates

First listed
Apr 28, 2016
Start date
Sep 22, 2016
Status verified
Feb 2018
Primary completion
Jan 19, 2018
Completion
Jan 19, 2018

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evogliptin
    Hepatic dysfunction, Healthy control

Primary Outcome Measure

Pharmacokinetic(Cmax of Evogliptin) [ Time Frame: Day1, Day2, Day3, Day4, Day5, Day6 ]

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