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This study evaluates the safety, tolerability and pharmacokinetics of Ammoxetine Hydrochloride Enteric-coated Tablets in Chinese heathy subjects. Part of the participants will receive Ammoxetine Hydrochloride Enteric-coated Tablets, while the other part will receive placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ammoxetine Hydrochloride Enteric-coated Tablets | Experimental | There will be 7 ascending cohorts . Each cohort will be administered in different dose once for 7 days. |
|
| Placebo Enteric-coated Tablets | Active Comparator | There will be 7 ascending cohorts. placebo enteric-coate tablets to mimic Ammoxetine Hydrochloride Enteric-coated tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ammoxetine Hydrochloride Enteric-coated Tablets | Drug | There will be 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. 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 Events | Incidence of Adverse Events that researchers determined clinical significance | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of blood sample | changes in blood concentration | 8 days |
| Mass balance | the metabolite analysis in sample of plasma, urine and fecal. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi Shen | Sichuan huaxi hospital 1 ward. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan huaxi hospital 1 ward. | Chengdu | Sichuan | 610000 | China |
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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 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested. |
|
| 8 days |
| Pharmacokinetics of urine sample | changes in urine concentration | 8days |