A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers

Yiling Pharmaceutical Inc.1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2019年12月17日最近更新: 2021年12月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Yiling Pharmaceutical Inc.
入组人数: 36
试验地点: 1
主要终点: Mean residence time (MRT) parameter

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To evaluate the tolerance and safety of FLA tablets in healthy volunteers.
To evaluate the pharmacokinetics of FLA tablets in healthy volunteers.
Provide basis for dosage setting for follow-up clinical research.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double-blind

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•18-65 years old (including upper and lower limits);
•Men and women are not limited;
•Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits);
•Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.

排除标准

•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;
•There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers;
•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;
•There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant;
•The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening;
•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;
•Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage;
•Those who participated in any clinical trial within 3 months before administration;
•Those who donated blood more than 400 mL or 2 units within 3 months before administration;
•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;
•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;
•Researchers do not consider it suitable for participants in this clinical study.

研究组 & 干预措施

FLZ-150mg experimental

Experimental

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.

干预措施: Phenlarmide Tablets (Drug)

FLZ-150mg placebo

Placebo Comparator

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.

干预措施: Placebos (Drug)

FLZ-600mg experimental

Experimental

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.

干预措施: Phenlarmide Tablets (Drug)

FLZ-600mg placebo

Placebo Comparator

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.

干预措施: Placebos (Drug)

FLZ-900mg experimental

Experimental

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.

干预措施: Phenlarmide Tablets (Drug)

FLZ-900mg placebo

Placebo Comparator

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.

干预措施: Placebos (Drug)