Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Design:Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and parallel control Objectives:
34 cases (including 4 cases of the pre- trial), of which the 150mg dose group is in the 4 cases of pre- trial (open, all accepted Finamine tablets orally, among whom, two receive it under fasting condition , and the other two receive it half an hour post a high-fat meal started). There are 6 cases in the formal trial (the subjects' ratio of investigational drug to placebo is 2:1). In all other dose groups, the subjects' ratio of investigational drug to placebo is 3:1.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-trial, fasting administration | Experimental | 2 cases were given 150mg Finamine tablets(pre-trial,fasting administration) |
|
| pre-trial,after high fat meal | Experimental | 2 cases were given 150mg Finamine tablets (pre- trial,after high fat meal) |
|
| formal trial-150mg | Placebo Comparator | 4 cases were given 150mg Finamine tablets 2 cases were given placebo |
|
| formal trial-300mg | Placebo Comparator | 6 cases were given 300mg Finamine tablets 2 cases were given placebo |
|
| formal trial-600mg | Placebo Comparator | 6 cases were given 600mg Finamine tablets 2 cases were given placebo |
|
| formal trial-1200mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Finamine tablets | Drug | taken Finamine tablets orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance evaluation | maximum tolerated dose(MTD)、dose-limiting toxicity(DLT) | From 0 to 96 hours after dosing |
| AE | The occurrence rate of AE. | From 0 to 96 hours after dosing |
| AUC0-96h | area under the concentration-time curve from the time of dosing extrapolated to the 96h after dosing. | From 0 to 96 hours after dosing |
| AUCinf | area under the concentration-time curve from the time of dosing extrapolated to time infinity. | From 0 to 96 hours after dosing |
| Peak Plasma Concentration (Cmax) | The PK parameters of the plasma sample. | From 0 to 96 hours after dosing |
| Tmax | The amount of time that a drug is present at the maximum concentration in serum. | From 0 to 96 hours after dosing |
| t1/2 | The PK parameters of the plasma sample. | From 0 to 96 hours after dosing |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
If being one of the following conditions, subjects cannot be selected
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shijiazhuang Yiling Pharmaceutical Co. Ltd | Shijiazhuang | Hebei | 050035 | China |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
6 cases were given 1200mg Finamine tablets 2 cases were given placebo |
|
|
| Placebo tablets | Drug | taken Placebo tablets orally |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |