The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
Oral SHR7280 tablet.
Oral SHR7280 placebo tablet.
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Peak concentration (Cmax)
Time frame: Day 1 to Day 8.
Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t)
Time frame: Day 1 to Day 8.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: Day 1 to Day 8.
Time to peak concentration (Tmax)
Time frame: Day 1 to Day 8.
Elimination half-life (t1/2)
Time frame: Day 1 to Day 8.
Adverse events (AEs)
Time frame: Day 1 to Day 15.
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