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The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Single dose of 34 mg Donepezil Dihydroxynaphthalate for Injection. |
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| Group 2 | Experimental | Single dose of 68 mg Donepezil Dihydroxynaphthalate for Injection. |
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| Group 3 | Experimental | Single dose of 136 mg Donepezil Dihydroxynaphthalate for Injection. |
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| Group 4 | Experimental | Single dose of 204 mg Donepezil Dihydroxynaphthalate for Injection. |
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| Group 5 | Experimental | Single dose of 306 mg Donepezil Dihydroxynaphthalate for Injection. |
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| Group 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil Dihydroxynaphthalate for Injection | Drug | HHT201 will be injected into the muscle of gluteus. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | AEs and their incidence | Up to 42 days |
| Number of Participants With Abnormal Laboratory Values | Number of Participants With Abnormal Laboratory Values | Up to 42 days |
| Number of Participants With Abnormal ECG QT Interval | Number of Participants With Abnormal ECG QT Interval | Up to 42 days |
| Number of Participants With Abnormal Vital signs | Number of Participants With Abnormal Vital signs | Up to 42 days |
| Number of Participants With Abnormal Physical examination | It's comprehensive system check by the doctor. | Up to 42 days |
| VAS | Score of Visual Analogue Scale, which is a scale from 0-10, with higher scores indicate more severe. | Up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Donepezil | Maximum observed concentration of drug substance in plasma. | Blood samples collected over a 42-day period |
| Tmax of Donepezil | Time when the maximum concentration is acheived |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongqing Lv | Contact | 86-0576-85199816 | lvdq@enzemed.com | |
| Zhanrong Ye | Contact | 86-0576-85199816 | Zoe.Ye@enzemed-crc.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongqing Lv | Zhejiang Taizhou Hospital Luqiao Hospital (Enze Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Province Taizhou Hospital Luqiao Hospital (Enze Hospital) (Taizhou Hospital Phase I Center) | Taizhou | Zhejiang | 318000 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Single dose of 408 mg Donepezil Dihydroxynaphthalate for Injection.
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| Blood samples collected over a 42-day period |
| AUC0-t of Donepezil | Area under the blood concentration-time curve from zero to the collection time t of the last measurable concentration. | Blood samples collected over a 42-day period |
| AUC0-∞ of Donepezil | Area under the concentration-time curve from time zero to infinity. | Blood samples collected over a 42-day period |
| t1/2z of Donepezil | The time when the concentraion of the drug eliminated to half of the initial. | Blood samples collected over a 42-day period |
| Vz/F | Apparent volume of distribution | Blood samples collected over a 42-day period |
| CLz/F | Apparent clearance | Blood samples collected over a 42-day period |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |