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| ID | Type | Description | Link |
|---|---|---|---|
| TPN672-KYHY-201801 | Other Identifier | Kanion Pharmaceutical |
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| Name | Class |
|---|---|
| Jiangsu Kanion Pharmaceutical Co. | OTHER |
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This is a single-site, randomized, double-blind, placebo-controlled, incremental phase I clinical trial to evaluate preliminarily the tolerance, pharmacokinetics and pharmacodynamic effects of TPN672 maleate in Chinese healthy volunteers after single dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.125mg single dose | Experimental | single dose of TPN-672 0.125mg, 2 subjects |
|
| 0.25mg single dose | Experimental | single dose of 0.25mg, 10 subjects (8 for TPN-672, 2 for placebo) |
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| 0.5mg single dose | Experimental | single dose of 0.5mg, 10 subjects (8 for TPN-672, 2 for placebo) |
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| 1mg single dose | Experimental | single dose of 1mg, 10 subjects (8 for TPN-672, 2 for placebo) |
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| 2mg single dose | Experimental | single dose of 2mg, 10 subjects (8 for TPN-672, 2 for placebo) |
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| 3mg single dose | Experimental | single dose of 3mg, 10 subjects (8 for TPN-672, 2 for placebo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPN-672 | Drug | single dose of TPN-672 maleate tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of Subjects with adverse events during clinical trial | 48 hours |
| Cmax | Maximum Plasma Concentration | 48 hours |
| AUC | Area Under the Curve | 48 hours |
| Tmax | Time to Cmax | 48 hours |
| T1/2 | Time of half life | 48 hours |
| ACR | Apparent Clearance Rate | 48 hours |
| ADV | Apparent Distribution Volume | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| prolactin | serum prolactin test | 48 hours |
| temperature | ear temperature | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifeng SHEN, MD PhD | Contact | 86-21-34773657 | shenyifeng@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Yifeng SHEN, MD PhD | Shanghai Mental Health Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| 4mg single dose | Experimental | single dose of 4mg, 10 subjects (8 for TPN-672, 2 for placebo) |
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| pulse rate | pulse rate | 48 hours |
| respiratory | frequency of respiratory per minute | 48 hours |
| blood pressure | lying blood pressureļ¼ systolic and diastolic | 48 hours |
| electrocardiogram(ECG) | the number of subjects with abnormal ECG report by 12-lead electrocardiogram | 48 hours |
| QTc | QTc interval | 48 hours |
| Extrapyramidal symptoms | Simpson Angus Rating Scale (SAS), total score ranges from 0 to 40, of which lower values represent a better outcome. | 48 hours |
| Involuntary Movement | Abnormal Involuntary Movement Scale (AIMS), total score ranges from 0 to 14, of which lower values represent a better outcome. | 48 hours |
| Akathisia | Barnes Akathisia Rating Scale (BARS), total score ranges from 0 to 40, of which lower values represent a better outcome. | 48 hours |
| IL-6 | Serum concentration of Interleukin-6 | 48 hours |
| IL-4 | Serum concentration of Interleukin-4 | 48 hours |
| IL-1 | Serum concentration of Interleukin-1 | 48 hours |
| IL-2 | Serum concentration of Interleukin-2 | 48 hours |
| INF-gamma | Serum concentration of Interferon-gamma | 48 hours |
| TNF-alpha | Serum concentration of Tumor necrosis factor-alpha | 48 hours |
| 5-HT | Serum concentration of serotonin | 48 hours |
| DA | Serum concentration of Dopamine | 48 hours |
| NE | Serum concentration of Norepinephrine | 48 hours |
| BDNF | Serum concentration of Brain-derived neurotrophic factor | 48 hours |
| Glutamic acid | Serum concentration of Glutamic acid | 48 hours |
| GABA | Serum concentration of gamma-aminobutyric acid | 48 hours |