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This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective Serotonin partial agonist and reuptake inhibitors, HEC113995PA•H2O,in healthy subjects.This study is the healthy adult subjects single ascending-dose research.
There have set up seven dose group(2.5、5、10、20、40、60、80mg).The first group(2.5mg)contains 8 health subjects(6 health subjects take experimental drugs,2 health subjects take the placebo). Other groups contains 10 health subjects(8 health subjects take experimental drugs,2 health subjects take the placebo).Within 30min before taking the medicine and after 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 24h, 36h, 48h,72h to take blood samples for pharmacokinetics(PK) detection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEC113995PA•H2O tablet | Experimental | Including 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
|
| placebo tablet | Placebo Comparator | Including 7 dose groups(2.5-、5、10-、20-、40-、60-、80mg).Each dose group was given only once.After an overnight stay of at least 10h on an empty stomach, 240mL of water was administered in the morning under the condition of an empty stomach. Water was forbidden for 1h before and 1h after administration, and fasting for 4h after administration. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEC113995PA•H2O tablet | Drug | 2.5-、5-、10-、20-、40-、60-、80mg HEC113995PA•H2O tablet in day1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of the single ascending-dose | To assess the safe and tolerability of the single ascending-dose | From the baseline to day4 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration(Cmax) | Maximum Plasma Concentration(Cmax)of HEC113995PA•H2O in single ascending-dose | Prior to dosing(0.5h)and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing |
| Area Under the Curve(AUC) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Residence Time(MRT) | Mean Residence Time(MRT) of HEC113995PA•H2O in single ascending-dose | Prior to dosing(0.5h)and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing |
| Terminal elimination half-life(T1/2) |
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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| Placebo tablet | Drug | 2.5-、5-、10-、20-、40-、60-、80mg Placebo tablet in day1. |
|
Area Under the Curve(AUC) of HEC113995PA•H2O in single ascending-dose
| Prior to dosing(0.5h)and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing |
| Maximum Peak Time(Tmax) | Maximum Peak Time(Tmax) of HEC113995PA•H2O in single ascending-dose | Prior to dosing(0.5h)and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing |
Terminal elimination half-life(T1/2) of HEC113995PA•H2O in single ascending-dose
| Prior to dosing(0.5h)and 0.5h,1h,1.5h,2h,2.5h,3h,4h,5h,6h,8h,10h,12h,24h,36h,48h,72h after dosing |