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This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fasted,fed | Experimental | Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively. |
|
| fed,fasted | Experimental | Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY03020 | Drug | single dose,administered orally for each period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) of LPM787000048 in plasma | up to Day 12 | |
| Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma | up to Day 12 | |
| Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma | up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum observed concentration (Tmax) of LPM787000048 in plasma | up to Day 12 | |
| Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma | up to Day 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing AnDing Hospital Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Number of participants with adverse events (AEs). |
| up to Day 12 |