A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China
Parkinson Disease
About this trial
This is an interventional other trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Age: 18 to 65 years old (including the upper and lower limits).
- Male or female
- Weight ≥50kg, BMI 18-28 kg/m2 (including the upper and lower limits).
- Understand and sign the informed consent form,able to understand the process and requirements of the study, and volunteer to participate in this study.
Exclusion Criteria:
If being one of the following conditions, subjects cannot be selected
- There is a history of disease in heart, liver, kidney, respiratory system, digestive tract, nervous system, endocrine system, immune system, blood system, etc., that the investigator has determined to be clinically significant;
- Abnormalities are in vital signs, comprehensive physical examinations, laboratory tests, ECG examinations, etc., and they are considered clinically significant by the investigator;
- Any drug was taken within two weeks prior to dosing in the study , and the investigators believe that this condition may affect the assessment results of this study;
- There is an seriously allergic history of food and drug or hypersensitivity that the investigator has identified as clinically significant;
- There are positive results of serological tests (HBsAg, anti-HCV, anti-HIV, or TP-Ab) during screening;
- Within 1 years prior to the administration of the drug, the history of drinking or drug abuse, that the investigator believes it may affect the evaluation results of the study. Or, during screening, the alcohol breath test or the urine screening test is positive.
- Subjects cannot quit smoking or quit drinking during the study period or subjects' carbon monoxide breath test is ≥7ppm during the screening period (when the investigator thinks it necessary, it can be further confirmed by urine cotinine test);
- Subjects participated in any drug clinical trial within 3 months prior to study dosing;
- Subjects donated blood ≥400mL or 2 units within 3 months prior to study dosing;
- Subjects do not agree to avoid the use of tobacco ,alcoholic beverages or caffeinated beverages, or to avoid strenuous exercise and other factors that influence such as absorption, distribution, metabolism, and excretion of drugs during 24 hours before dosing in the trial and in the duration of the trial;
- Pregnant or breastfeeding women, or subjects who are tested positive for serum HCG before dosing in the trial, or who are unable or unwilling to take contraception approved by researchers during the study period as directed by the investigator;
- Subjects who, in the opinion of nvestigators, are not suitable for participating in this clinical study.
Sites / Locations
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
pre-trial, fasting administration
pre-trial,after high fat meal
formal trial-150mg
formal trial-300mg
formal trial-600mg
formal trial-1200mg
2 cases were given 150mg Finamine tablets(pre-trial,fasting administration)
2 cases were given 150mg Finamine tablets (pre- trial,after high fat meal)
4 cases were given 150mg Finamine tablets 2 cases were given placebo
6 cases were given 300mg Finamine tablets 2 cases were given placebo
6 cases were given 600mg Finamine tablets 2 cases were given placebo
6 cases were given 1200mg Finamine tablets 2 cases were given placebo