1. To evaluate the safety and tolerability of Phenlarmide tablets in patients with Parkinson's disease in the early and middle stages. 2. To evaluate the pharmacokinetics of Phenlarmide tablets in patients with Parkinson's disease. 3. To explore the efficacy of Phenlarmide tablets in the treatment of early and mid-term Parkinson's disease.
1. Objective to evaluate the tolerance and safety of multiple administration of fenloramide tablets in patients with early and mid-term Parkinson's disease: To evaluate the adverse events of DLT and MTD, adverse reactions, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine), vital signs, 12 lead ECG and physical examination of fenloramide tablets in patients with early and mid-term Parkinson's disease . 2. Objective to evaluate the pharmacokinetics of fenloramide tablets in patients with Parkinson's disease in early and middle stages. The main PK parameters included Tmax, SS, Cmax, SS, cavg, SS, Ke, T1 / 2, Cl / F (only fenloramide prototype), VZ / F (only fenloramide prototype), auc0-24, SS, aucinf, SS, auc0 last, SS, AUC\_ %Extrap, DF, etc. 3. Objective to explore the efficacy of fenloramide tablets in the treatment of early and mid-term Parkinson's disease, and to observe the changes of UPDRS and CGI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
40
Dosage form:Tablet; Give the medicine once a day,4 weeks is a cycle of administration, a total of 3 cycles of administration.
Dosage form:Tablet; Give the medicine once a day,4 weeks is a cycle of administration, a total of 3 cycles of administration.
Chen Biao
Beijing, Beijing Municipality, China
the dose limiting toxicity (DLT)
The occurrence of Dose limiting toxicity.
Time frame: through study completion, an average of 6 months
Tmax, ss
After administration, the time when the highest concentration of drug appeared in plasma
Time frame: 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.
Time frame: through study completion, an average of 6 months
maximum tolerable dose (MTD)
The occurrence of Maximum tolerable dose.
Time frame: through study completion, an average of 6 months
adverse events
The occurrence rate of adverse events.
Time frame: through study completion, an average of 6 months
adverse reactions
The occurrence rate of adverse reactions
Time frame: 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
Time frame: through study completion, an average of 6 months
blood biochemistry
The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected
Time frame: through study completion, an average of 6 months
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coagulation function
Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of 6 months
Body temperature
One of the vital signs.
Time frame: through study completion, an average of 6 months
12 lead ECG
Evaluation of QT interval
Time frame: through study completion, an average of 6 months
Blood pressure
Assess whether systolic blood pressure and diastolic blood pressure are normal.
Time frame: through study completion, an average of 6 months
Heart rate
One of the vital signs.
Time frame: through study completion, an average of 6 months
Breathing
Assess if breathing is normal
Time frame: through study completion, an average of 6 months
Cmax, ss
The highest concentration of the drug in the plasma after administration
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 6 months
CL/F (fenoxamide prototype only)
The amount of a substance excreted by the kidney per minute
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 6 months
AUC_%Extrap
the area under the curve that has been derived after extrapolation of Residual Area
Time frame: through study completion, an average of 6 months
DF
The index reflecting the unbalanced situation of transportation in time
Time frame: through study completion, an average of 6 months