This is a randomized, open label, single dose, two-period, crossover trial phase I study. The purpose of this study is to evaluate the food effect on the pharmacokinetics(PK) of SIM0270 after oral administration under fasted, standard meal, or high-fat diet conditions.
Part A High Fat Meal Test: Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 1 and Group 2) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or high-fat diet conditions. Part B Standard Meal Test (optional part): Sixteen healthy adult subjects are planned to be enrolled and randomly assigned to different dosing sequence groups (Group 3 and Group 4) in a 1:1 ratio for a two-period crossover trial. The subjects administered a single dose of SIM0270 under fasted, or standard meal conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Use according to the prescribed protocol
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
PK parameters: Peak Plasma Concentration (Cmax)
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
Time frame: Day1 to Day 37
PK parameters:Area under the plasma concentration versus time curve (AUC)
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
Time frame: Day1 to Day 37
PK parameters: Half-life (t1/2)
Comparison of PK parameters of SIM0270 single dose in Chinese healthy adult subjects under fasted/ high-fat diet conditions, or under fasted/ standard meal conditions.
Time frame: Day1 to Day 37
Adverse events
The incidence and grading of adverse events, as well as abnormal indicators of vital signs, physical examination, electrocardiogram, and laboratory tests.
Time frame: From signing ICF until 18 days after the last dose of medication
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