Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction
- Registration Number
- NCT02754219
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
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
- Detailed Description
When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
<Hepatic Dysfunction>
- At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
- Child-Pugh A or B
<Healthy Control>
- Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject
Exclusion Criteria
<Hepatic Dysfunction>
- Child-Pugh C
- History of Liver transplant
<Healthy Control>
- History of chronic liver disorders
- Pregnant or lactating women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evogliptin Evogliptin Hepatic dysfunction, Healthy control
- Primary Outcome Measures
Name Time Method Pharmacokinetic(Cmax of Evogliptin) Day1, Day2, Day3, Day4, Day5, Day6
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Severance Hospital Clinical Trial Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital Clinical Trial Center🇰🇷Seoul, Korea, Republic of