Hyperuricemia Clinical Trial
Official title:
A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Subject has a body mass index =18 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. ALT?AST?TBIL>ULN; 3. History of kidney stones or screening kidney stones by B-ultrasound; 4. History of malignancy; 5. History of xanthinuria; 6. Donated blood(=400ml)within 3 months prior to screening or received transfusion of blood? |
Country | Name | City | State |
---|---|---|---|
China | The Affiliated Hospital of QingDao University | Qingdao | Shan Dong |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 | ||
Primary | Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 | ||
Secondary | Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 | ||
Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events | Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc. | Clinical significant changes from Day-21 up to Day 29 |
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