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The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.
The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical, physical examination, and routine laboratory assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group 1 | Experimental | HHT201 17mg injection |
|
| experimental group 2 | Experimental | HHT201 34mg injection |
|
| experimental group 3 | Active Comparator | Donepezil Hydrochloride oral tablet 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Donepezil Pamoate for Injection 17mg | Drug | A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Donepezil | Maximum observed concentration of drug substance in plasma. | Blood samples collected over a 35 days period |
| Tmax of Donepezil | Time when the maximum concentration is acheived | Blood samples collected over a 35 days period |
| AUClast of Donepezil | Area under the concentration-time curve from time zero to time of last measurable concentration. | Blood samples collected over a 35 days period |
| AUC0-∞ of Donepezil | Area under the concentration-time curve from time zero to infinity. | Blood samples collected over a 35 days period |
| t1/2 of Donepezil | The time when the concentraion of the drug eliminated to half of the initial. | Blood samples collected over a 35 days period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huafang Li, PhD | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai mental health center | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D000077265 | Donepezil |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007189 | Indans |
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| Donepezil Pamoate for Injection 34mg | Drug | A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once. |
|
|
| Donepezil Hydrochloride 5mg | Drug | A tablet of 5mg Donepezil Hydrochloride will be administered once. |
|
|
| D007192 |
| Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |