The study is a randomized , open-label, two-stage crossover food effect study of single doses of DDO-3055 tablets in healthy subjects. 14 healthy subjects were randomly divided into groups A and B, 7 subjects in each group. Two stage washout period is 6 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
DDO-3055 tablet, 2 single doses separated by 6 days.
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Area under the concentration-time curve (AUC) of DDO-3055
Time frame: up to 2 days
Maximum plasma concentration (Cmax) of DDO-3055
Time frame: up to 2 days
Time to maximum observed serum concentration (Tmax) of DDO-3055
Time frame: up to 2 days
Terminal elimination half-life (T1/2) of DDO-3055
Time frame: up to 2 days
Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055
Time frame: up to 2 days
Apparent volume of distribution after oral administration (V/F) of DDO-3055
Time frame: up to 2 days
Change of endogenous erythropoietin from baseline
Time frame: up to 2 days
Safety and tolerability
Use the incidence and severity of adverse events to assess safety and tolerability
Time frame: up to 9 days
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