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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLZ-150mg experimental | Experimental | Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. |
|
| FLZ-150mg placebo | Placebo Comparator | Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. |
|
| FLZ-600mg experimental | Experimental | Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. |
|
| FLZ-600mg placebo | Placebo Comparator | Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. |
|
| FLZ-900mg experimental | Experimental | Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenlarmide Tablets | Drug | Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance evaluation index | maximum tolerated dose (MTD), dose limited toxicity (DLT) | From 0 to 20 days after dosing |
| Tmax | The amount of time that a drug is present at the maximum concentration in serum. | From 0 to 168 hours after the first dose |
| Peak Plasma Concentration (Cmax) | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| t1/2 | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| Vz/F | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| CL/F | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| Mean residence time (MRT) parameter | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| Kel | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking union medical college hospital | Beijing | Beijing Municipality | 100032 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Double-blind
|
| FLZ-900mg placebo | Placebo Comparator | Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17. |
|
|
| Placebos | Drug | Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17. |
|
|
| Area under the plasma concentration versus time curve (AUC0-∞) | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| AUC0-24 | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| AUC0-72 | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| AUC0-last | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose |
| Tmax, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| Cmax, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| Cmin, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| Cavg, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| t1/2, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| AUC0-24, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| AUC0-72, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| AUC0-∞, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| AUC0-last, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |