This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration
The whole trial consisted of three parts: Part 1 was a single-center, randomized, double-blind, placebo-controlled, single-dose dose increasing safety, tolerability and pharmacokinetic test; Part 2 was a single-center, randomized, double-blind, placebo-controlled, multiple-dose safety, tolerability and pharmacokinetic study. Part 3 is a single-dose, randomized, open, two-phase, double-cross, two-sequence design trial of the effects of food on the main PK parameters of SHEN211 tablets in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
76
SHEN211 tablets, tablets, specification: 0.11g, 10 tablets/box, storage: sealed, not more than 25℃ storage.
placebo tablets, tablets, specification: 0g, 10 tablets/box, storage: sealed, not more than 25℃ storage.
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province)
Jinan, Shandong, China
RECRUITINGIncidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and Tolerability as assessed by AEs and SAEs
Time frame: Up to day 63
Tmax
Peak time: The time required to reach peak concentration after administration
Time frame: Up to day 63
Cmax
Peak concentration: The highest blood concentration after administration
Time frame: Up to day 63
AUC
Area under the drug time curve: The area surrounded by the blood concentration curve to the time axis.
Time frame: Up to day 63
λz
Terminal elimination rate: The terminal elimination rate constant is obtained from the semilog linear regression of the phase elimination concentration point
Time frame: Up to day 63
t1/2
Terminal elimination half-life: The time required for the terminal phase blood concentration to decrease by half
Time frame: Up to day 63
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