Hyperuricemia
Conditions
Brief summary
The objective of the study is to assess the Safety and Efficacy of SHR4640 and Febuxostat in patients with Hyperuricemia.
Interventions
DRUGSHR4640 dose1 plus Febuxostat dose1
Tablet,dose1,QD
DRUGSHR4640 dose1 plus Febuxostat dose2
Tablet,dose1, dose2 QD
DRUGSHR4640 dose2 plus Febuxostat dose3
Tablet,dose2, dose3 QD
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject has a body mass index ≥18 and ≤30 kg/m2; * Screening sUA value ≥8mg/dl; * Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.
Exclusion criteria
* Subject known or suspected of being sensitive to the study drugs or its ingredient； * ALT、AST、TBIL\>1.5ULN; * History of kidney stones or screening kidney stones by B-ultrasound； * History of malignancy； * History of xanthinuria； * Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events(AEs) and Serious Adverse Events(SAEs) | Up to week 4 | Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events, incidence of drug related adverse events (safety and tolerability) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with a serum uric level≤360μmol/L | At week1, 2, 3 and 4 |
| Percentage change from baseline in serum uric level . | At week1, 2, 3 and 4 |
| Actual change from baseline in serum uric level | At week1, 2, 3 and 4 |
Contacts
Primary ContactLiu Yi
Outcome results
None listed