The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Southwest Hospital
Chongqing, Sichuan, China
Adverse events
Time frame: Clinical significant changes from baseline up to to Day 15; from baseline up to Day 19 for 7.5mg dose group
Peak Plasma Concentration (Cmax)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Area under the plasma concentration versus time curve (AUC)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Half-time (T1/2)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Time to the peak plasma concentration (Tmax)
Time frame: up to day 4; up to day 11 for 7.5mg dose group
Cmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
AUC of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
T1/2 of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
Tmax of SHR4640 dosed after high-fat meal in 7.5mg dose group
Time frame: up to day 11
Changes in serum uric acid concentration from baseline
absolute and percent changes in serum acid concentration
Time frame: up to day 4; up to day 11 for 7.5mg dose group
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Changes in urinary uric acid excretion from baseline
percent changes in urinary uric acid excretion from baseline
Time frame: up to day 4; up to day 11 for 7.5mg dose group