The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014, China
NCT Number: NCT06536036
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250014, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Use according to the prescribed protocol
Time frame: Day1 to Day 37
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
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
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: From signing ICF until 18 days after the last dose of medication
The incidence and grading of adverse events, as well as abnormal indicators of vital signs, physical examination, electrocardiogram, and laboratory tests.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Industry
A Single Center, Randomized, Open Label, Single Dose, Two-Period, Crossover Phase I Study to Evaluate the Effect of Food (high-fat/standard Meal) on the Pharmacokinetics of SIM0270 in Healthy Adult Subjects in China
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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