Parkinson Disease
Conditions
Keywords
Tolerance, Safety, Pharmacokinetic characteristics
Brief summary
1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers. 2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers. 3. Provide basis for dosage setting for follow-up clinical research.
Interventions
DRUGPhenlarmide Tablets
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.
DRUGPlacebos
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.
Sponsors
Yiling Pharmaceutical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 1)18-65 years old (including upper and lower limits); * 2)Men and women are not limited; * 3)Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits); * 4)Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.
Exclusion criteria
* 1)There is a history of heart, liver, kidney, respiratory, digestive tract, nervous system, endocrine, immune or hematological diseases judged by researchers as having clinical significance; * 2)There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers; * 3)Any drug was taken within two weeks before the study was administered, and the researchers believe that this condition may affect the evaluation results of the study; * 4)There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant; * 5)The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening; * 6)One year before the study was administered, some researchers believed that alcohol or drug abuse history might affect the results of this study, or that alcohol breath test or urine drug screening test were positive during screening; * 7)Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage; * 8)Those who participated in any clinical trial within 3 months before administration; * 9)Those who donated blood more than 400 mL or 2 units within 3 months before administration; * 10)Do not agree to avoid the use of tobacco, alcohol or caffeine-containing beverages within 24 hours before and during the trial, or to avoid vigorous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism and excretion; * 11)Pregnant or lactating women, or those with positive serum HCG test before administration, or those who are unable or unwilling to adopt contraceptive measures approved by the researchers during the study period and within three months after the end of the study, as directed by the researchers; * 12)Researchers do not consider it suitable for participants in this clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tmax, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| Cmax, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| Cmin, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| Cavg, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| t1/2, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| CL/F | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| Mean residence time (MRT) parameter | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| Kel | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| Area under the plasma concentration versus time curve (AUC0-∞) | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| AUC0-24 | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| AUC0-72 | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| AUC0-last | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| Tolerance evaluation index | From 0 to 20 days after dosing | maximum tolerated dose (MTD), dose limited toxicity (DLT) |
| Tmax | From 0 to 168 hours after the first dose | The amount of time that a drug is present at the maximum concentration in serum. |
| Peak Plasma Concentration (Cmax) | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| t1/2 | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| Vz/F | From 0 to 168 hours after the first dose | The PK parameters of the plasma sample |
| AUC0-24, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| AUC0-72, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| AUC0-∞, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
| AUC0-last, ss | From 0 to 72 hours after the last dose | The PK parameters of the plasma sample |
Countries
China
Outcome results
None listed