Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

• Status: Completed
• Trial end date: 2018-01-19
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.

Criteria

Inclusion Criteria:

• At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)

• Child-Pugh A or B

• Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject

Exclusion Criteria:

• Child-Pugh C

• History of Liver transplant

• History of chronic liver disorders

• Pregnant or lactating women