A Clinical Study Trial of Phenlarmide in China
Phase 1
Completed
- Conditions
- Parkinson Disease
- Interventions
- Drug: Phenlarmide TabletsDrug: Placebos
- Registration Number
- NCT04164121
- Lead Sponsor
- Yiling Pharmaceutical Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FLZ-600mg experimental Phenlarmide Tablets Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. FLZ-150mg placebo Placebos Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. FLZ-900mg placebo Placebos Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17. FLZ-150mg experimental Phenlarmide Tablets Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. FLZ-600mg placebo Placebos Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. FLZ-900mg experimental Phenlarmide Tablets Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17.
- Primary Outcome Measures
Name Time Method 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
Cavg, 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 From 0 to 168 hours after the first dose The PK parameters of the plasma sample
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.
Vz/F 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
AUC0-72 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)
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
CL/F 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
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
t1/2, 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
Cmin, ss From 0 to 72 hours after the last 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-last, ss From 0 to 72 hours after the last dose The PK parameters of the plasma sample
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Peking union medical college hospital
🇨🇳Beijing, Beijing, China