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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLZ-150mg | Experimental | Drug:Phenlarmide;Dosage:150mg; |
|
| FLZ-300mg | Experimental | Drug:Phenlarmide;Dosage:300mg; |
|
| FLZ-600mg | Experimental | Drug:Phenlarmide;Dosage:600mg; |
|
| FLZ-900mg | Experimental | Drug:Phenlarmide;Dosage:900mg; |
|
| Placebo-150mg | Placebo Comparator | Drug:Placebo;Dosage:150mg; |
|
| Placebo-300mg | Placebo Comparator | Drug:Placebo;Dosage:300mg; |
|
| Placebo-600mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenlarmide | Drug | Dosage form:Tablet; Give the medicine once a day,4 weeks is a cycle of administration, a total of 3 cycles of administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the dose limiting toxicity (DLT) | The occurrence of Dose limiting toxicity. | through study completion, an average of 6 months |
| Tmax, ss | After administration, the time when the highest concentration of drug appeared in plasma | through study completion, an average of 6 months |
| Efficacy evaluation | explore the efficacy of fenolamide tablets in the treatment of early and middle stage Parkinson's disease, and observe the changes of UPDRS and CGI. | through study completion, an average of 6 months |
| maximum tolerable dose (MTD) | The occurrence of Maximum tolerable dose. | through study completion, an average of 6 months |
| adverse events | The occurrence rate of adverse events. | through study completion, an average of 6 months |
| adverse reactions | The occurrence rate of adverse reactions | through study completion, an average of 6 months |
| blood routine | Check whether the red blood cell system, white blood cell system and platelet system are normal | through study completion, an average of 6 months |
| blood biochemistry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| biao chen | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chen Biao | Beijing | Beijing Municipality | 100053 | 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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| Placebo Comparator |
Drug:Placebo;Dosage:600mg; |
|
| Placebo-900mg | Placebo Comparator | Drug:Placebo;Dosage:900mg; |
|
|
| Placebo | Drug | Dosage form:Tablet; Give the medicine once a day,4 weeks is a cycle of administration, a total of 3 cycles of administration. |
|
|
The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected |
| through study completion, an average of 6 months |
| coagulation function | Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated. | through study completion, an average of 6 months |
| urine routine | Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar. | through study completion, an average of 6 months |
| stool routine | Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs. | through study completion, an average of 6 months |
| Body temperature | One of the vital signs. | through study completion, an average of 6 months |
| 12 lead ECG | Evaluation of QT interval | through study completion, an average of 6 months |
| Blood pressure | Assess whether systolic blood pressure and diastolic blood pressure are normal. | through study completion, an average of 6 months |
| Heart rate | One of the vital signs. | through study completion, an average of 6 months |
| Breathing | Assess if breathing is normal | through study completion, an average of 6 months |
| Cmax, ss | The highest concentration of the drug in the plasma after administration | through study completion, an average of 6 months |
| Cavg, ss | The quotient of the area under the plasma concentration time curve divided by the interval time within a dose interval after the plasma concentration reaches the steady state. | through study completion, an average of 6 months |
| Ke | The ratio of the amount of compound eliminated from the body to the total amount in the body in unit time | through study completion, an average of 6 months |
| t1/2 | The time required for the concentration of a drug to drop by half in an organism | through study completion, an average of 6 months |
| CL/F (fenoxamide prototype only) | The amount of a substance excreted by the kidney per minute | through study completion, an average of 6 months |
| Vz/F (fenoxamide prototype only) | After the drug reaches dynamic equilibrium in the body, the ratio of the drug dose in the body to the blood concentration is called the apparent distribution volume | through study completion, an average of 6 months |
| AUC0-24, ss | After administration, the area under the 0-24 hour time curve of blood concentration absorbed into human circulation | through study completion, an average of 6 months |
| AUCinf, ss | After administration, the area under the time curve of 0-infinity of the blood concentration absorbed into human circulation | through study completion, an average of 6 months |
| AUC0-last,ss | After administration, the area under the time curve of 0-the last accurately determined sample collection time of the blood concentration absorbed into human circulation | through study completion, an average of 6 months |
| AUC_%Extrap | the area under the curve that has been derived after extrapolation of Residual Area | through study completion, an average of 6 months |
| DF | The index reflecting the unbalanced situation of transportation in time | through study completion, an average of 6 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |