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| Name | Class |
|---|---|
| Nanjing Zaiming Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-fat meal group(Group1) | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under high-fat diet condition in the second cycle. |
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| High-fat meal group(Group2) | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under high-fat diet condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle. |
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| Standard meal group(Group3) | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under fasting condition in the first cycle, and administered single dose of 60mg SIM0270 under standard meal condition in the second cycle. |
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| Standard meal group(Group4) | Experimental | Eight subjects were enrolled and administered single dose of 60mg SIM0270 under standard meal condition in the first cycle, and administered single dose of 60mg SIM0270 under fasting condition in the second cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM0270 | Drug | Use according to the prescribed protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day1 to Day 37 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | The incidence and grading of adverse events, as well as abnormal indicators of vital signs, physical examination, electrocardiogram, and laboratory tests. | From signing ICF until 18 days after the last dose of medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Jinan | Shandong | 250014 | China |
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