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The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEC83518 tablets | Experimental | There will be a total of 7 dose cohorts: 5 mg,10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg. |
|
| placebo tablets | Placebo Comparator | There will be a total of 6 dose cohorts: 10 mg, 20 mg, 40 mg, 80 mg, and 140 mg,200 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC83518 tablets | Drug | Each dose of HEC83518 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Adverse Events (AEs) | Safety and Tolerability of HEC83518 by Assessment of the Number of Adverse Events (AEs) Following Administration in Single Ascending Dose . | up to 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters - AUC0-∞ | area under the concentration versus time curve (AUC) from time zero to infinity | up to 96 hours |
| PK parameters - Cmax | Geometric Mean of Maximum Observed Plasma Concentration of HEC83518 |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacodynamics of HEC83518 tablets | The pharmacodynamics of HEC83518 was preliminarily explored through KSS (Karolinska sleepiness Scale, Karolinska Sleepiness Scale) and sleep monitoring instrument | up to 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Shanghai xuhui district central hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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All are double-blind except the pre-trial group
| Placebo | Drug | placebo |
|
| up to 96 hours |
| PK parameters -tmax | time to peak | up to 96 hours |
| PK parameters -t½ | apparent terminal elimination half-life | up to 96 hours |
| PK parameters -Vz/F | apparent volume of distribution | up to 96 hours |
| PK parameters - MRT | the Mean Residence Time | up to 96 hours |
| PK parameters -CL/F | the Apparent Clearance | up to 96 hours |
| D001523 |
| Mental Disorders |