The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout

• Status: Completed
• Trial end date: 2018-01-29
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Colchicine; Febuxostat

Criteria

Inclusion Criteria:

1. Subject has a body mass index ≥18.5 and ≤30 kg/m2;

2. Screening sUA value ≥8mg/dl;

3. Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.

Exclusion Criteria:

1. Subject known or suspected of being sensitive to the study drugs or its ingredient；

2. sCr>ULN;

3. History of kidney stones or screening kidney stones by B-ultrasound；

4. History of malignancy within 5 years；

5. History of xanthinuria；

6. Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。