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This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ammoxetine Hydrochloride Enteric-coated Tablets | Experimental |
| |
| Placebo Enteric-coated Tablets | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ammoxetine Hydrochloride Enteric-coated Tablets | Drug | There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Event | Incidence of Adverse Events that researchers determined clinical significance | 15 days |
| Area under the plasma concentration time curve (AUC) | The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets | 11 days |
| Maximum concentration (Cmax) | The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets | 11 days |
| Half life Period (t1/2) | The pharmacokinetics(PK) profile of Ammoxetine Hydrochloride Enteric-coated Tablets | 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| placebo enteric-coated tablets | Drug | There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested |
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