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Evaluate the effect of food on the pharmacokinetics of TQB3101 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3101: Fed + Fast | Experimental | In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fed condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fasted condition on Day 1 of treatment period 2. |
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| TQ-B3101: Fast+Fed | Experimental | In each of the two study periods (separated by a washout period),a single dose of TQ-B3101 will be administered.Participants will receive TQ-B3101 in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of TQ-B3101 in fed condition on Day 1 of treatment period 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3101 | Drug | TQ-B3101 oral capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | maximum concentration of the analyte in plasma | pre-dosing on Day 1 up to 144 hours post-dosing |
| Tmax | Time to Reach the Maximum Observed Plasma Concentration (Cmax) of the analyte | pre-dosing on Day 1 up to 144 hours post-dosing |
| AUC0-t | Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration of the analyte | pre-dosing on Day 1 up to 144 hours post-dosing |
| AUC0-inf | Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time of the analyte | pre-dosing on Day 1 up to 144 hours post-dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital of Fudan University | Shanghai | Shanghai Municipality | 200000 | China |
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