A Clinical Study Trial of Phenlarmide in China

Yiling Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Placebos; Drug: Phenlarmide Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT04164121

FLZPD1002

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 6 patient groups, including a placebo group

FLZ-150mg experimental

Experimental group

Description:

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.

Treatment:

Drug: Phenlarmide Tablets

FLZ-150mg placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos

FLZ-600mg experimental

Experimental group

Description:

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.

Treatment:

Drug: Phenlarmide Tablets

FLZ-600mg placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos

FLZ-900mg experimental

Experimental group

Description:

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.

Treatment:

Drug: Phenlarmide Tablets

FLZ-900mg placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebos