Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.

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

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• 18 years to 75 years (inclusive)

• Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)

• Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)

Exclusion Criteria:

• allergic to SGLT2 inhibitor analogues or any other similar structure;

• lactose intolerance history or lactose intolerance;

• Suspected or diagnosed as liver cancer or with other malignant tumors;

• Alcoholic liver, autoimmune liver disease, liver transplantation history