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This study is a single-center, randomized, open, double-cycle and double-cross and self-reflection phase Ic clinical trial, to evaluate effect and safety of high fat diet on pharmacokinetics of SPH3127 tablets.
Two panels, each consisting of ten participants (The number of single-sex subjects is not less than 1/3 of the total number) will be randomized to A or B groups.
Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH3127 200mg Panel A | Experimental | Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast. |
|
| SPH3127 200mg Panel B | Experimental | Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 200mg Panel A | Drug | Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma area under curve（AUC）(0-∞) of SPH3127 3127 | to evaluate the area under curve（AUC）(0-∞) of SPH3127 by feeding | Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose |
| Plasma Cmax of SPH3127 | to evaluate the Cmax of SPH3127 by feeding | Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose |
| Plasma Tmax of SPH3127 | to evaluate the Tmax of SPH3127 by feeding | Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose |
| Apparent terminal half-life of SPH3127 | to evaluate the Apparent terminal half-life of SPH3127 by feeding | Before dose, and at 0.17 hours、0.33h、0.5h、0.75h、1h、1.25h、1.5h、2h、4h、6h、8h、12h、24h hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with SPH3127 | Baseline to 10-13 days post last dose |
| Change from baseline in laboratory hematology values |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The capital medical university affiliated Beijing anzhen hospital | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000709209 | SPH3127 |
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|
| SPH3127 200mg Panel B | Drug | Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis. |
|
|
to evaluate the change from baseline in laboratory hematology values |
| Baseline to 10-13 days post last dose |
| Change from baseline in laboratory chemistry values | to evaluate the Change from baseline in laboratory chemistry values | Baseline to 10-13 days post last dose |
| Change from baseline in ECG | to evaluate the from baseline in ECG | Baseline to 10-13 days post last dose |