A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalated Phase I Clinical Study Trial to Evaluate the Tolerance and Pharmacokinetics of Felbinac Trometamol Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Tolerance evaluation index
研究概览
简要总结
- To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
- To evaluate the pharmacokinetic characteristics in healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions;
- •Be able to complete the research according to the clinical trial protocol;
- •Subjects have no pregnancy plan within the next 6 months and voluntarily take effective contraceptive measures;
- •Male and female subjects between 18 and 45 years (inclusive) of age;
- •Male subjects weighing no less than 50 kg, female subjects weighing no less than 45 kg.Body Mass Index (BMI) 18 to 28 kg/m2 (inclusive);
- •Health status: no clinical histories with clinical significance about heart, liver, kidney, digestive tract, nervous system, respiratory system (such as asthma), mental disorders and metabolic abnormalities and so on;
- •Physical examination, vital signs normal or no clinical significance.
排除标准
- •Someone smoking more than 5 pieces per day within the 3 months before the trial ；
- •Allergies, such as allergies to two or more drugs, food and pollen, or known to the drug component or ethylbenzene ethyl acetate allergy;
- •Having a history of drug and / or alcohol abuse (14 units of alcohol per week: 1 units = beer 285 mL, or 25 mL of spirits, or 100 mL of wine)；
- •Blood donation or extensive blood loss (> 400 mL) within three months of the use of the study drug;
- •Taked any drug that changes liver enzyme activity 28 days prior to the use of the study drug;
- •Taked any prescription, OTC drugs, any vitamin products or herbs within 14 days prior to the use of the study drug;
- •Two weeks before the trial took a special diet (including dragon fruit, mango, grapefruit, and / or rich in xanthine diet, etc.) or strenuous exercise, and other avtivites that affect drug absorption, distribution, metabolism, excretion and so on;
- •Combined with the following CYP3A4, p-gp or Bcrp inhibitors or inducers, such as itraconazole, ketoconazole or dronedarone;
- •There have been significant changes in diet or exercise habits recently;
- •Taked research drugs within three months prior to the use of the study drug or participating in any drug clinical trial;
- •Suffering from any increased risk of hemorrhagic disease, such as hemorrhoids, acute gastritis or stomach and duodenal ulcers;
- •ECG has clinical significance;
- •Female subjects are in lactation or serum pregnancy test are positive during screening or during the test.
- •Clinical laboratory tests are abnormal and have clinical significance, or other clinical findings showing clinically significant diseases (including but not limited to gastrointestinal, renal, liver, nerves, blood, endocrine, neoplasms, lungs, immunizations, mental or heart Cerebrovascular disease);
- •hepatitis (including hepatitis B and hepatitis C), AIDS, syphilis screening test positive;
- •Acute disease occurs before screening or using test drug;
- •Taking chocolate, any caffeine, or xanthine-rich food or drink at least 48 hours prior to the use of the study drug;
- •Taking any alcoholic products within 24 hours prior to the use of the study drug;
- •Alcohol or drug screening positive or drug abuse history over the past five years or 3 months before the trial used by drug users.
研究组 & 干预措施
group1
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:11.78mg Volume:0.50ml Frequency:Once Duration:30min A total of 10 subjects, 2 subjects served as pre-test groups, given to the test drug；the remaining 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Felbinac Trometamol Injection (Drug)
group1
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:11.78mg Volume:0.50ml Frequency:Once Duration:30min A total of 10 subjects, 2 subjects served as pre-test groups, given to the test drug；the remaining 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Placebo (Drug)
group2
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:23.56mg Volume:1.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Felbinac Trometamol Injection (Drug)
group2
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:23.56mg Volume:1.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Placebo (Drug)
group3
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:47.13mg Volume:2.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Felbinac Trometamol Injection (Drug)
group3
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:47.13mg Volume:2.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Placebo (Drug)
group4
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:94.25mg Volume:4.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Felbinac Trometamol Injection (Drug)
group4
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:94.25mg Volume:4.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Placebo (Drug)
group5
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:164.92mg Volume:7.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Felbinac Trometamol Injection (Drug)
group5
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:164.92mg Volume:7.00ml Frequency:Once Duration:30min A total of 8 subjects,6 received the test drug and 2 received the placebo.
干预措施: Placebo (Drug)
group6
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:259.16mg Volume:11.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min
干预措施: Felbinac Trometamol Injection (Drug)
group6
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:259.16mg Volume:11.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min
干预措施: Placebo (Drug)
group7
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:377.00mg Volume:16.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min
干预措施: Felbinac Trometamol Injection (Drug)
group7
Generic name:Felbinac Trometamol Injection;Placebo: normal saline Dosage form:Injection Dosage:377.00mg Volume:16.00ml Frequency:Once A total of 8 subjects,6 received the test drug and 2 received the placebo. Duration:30min
干预措施: Placebo (Drug)
结局指标
主要结局
Tolerance evaluation index
时间窗: up to 48.5 hours
percent of subjects with adverse reactions
次要结局
- Tmax(up to 48.5 hours)
- Mean residence time (MRT) parameter.(up to 48.5 hours)
- Peak Plasma Concentration (Cmax)(up to 48.5 hours)
- Vd(up to 48.5 hours)
- AUC0-48.5(up to 48.5 hours)
- Ae0-48.5(up to 48.5 hours)
- CLr(up to 48.5 hours)
- t1/2(up to 48.5 hours)
- Ke(up to 48.5 hours)
- Area under the plasma concentration versus time curve (AUC0-∞)(up to 48.5 hours)
- Fe(up to 48.5 hours)