Hyperuricemia
Conditions
Brief summary
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.
Interventions
DRUGSHR4640 dose1
Tablet,dose1,QD
DRUGFebuxostat dose2
Tablet,dose2,QD
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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。
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 |
| Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma | Day1 to Day 14 | — |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events | Clinical significant changes from Day-21 up to Day 29 | Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc. |
Countries
China
Contacts
Primary ContactCao Yu
Outcome results
None listed