Human Bioequivalence Test of Liraglutide Injection
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum (peak) plasma drug concentration(Cmax)
研究概览
简要总结
To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so as to provide reference for clinical evaluation and clinical medication;To observe the safety of the test preparation liraglutide injection and the reference preparation Victoza ® in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 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, fully understand the trial purpose, process and possible adverse reactions;
- •Able to complete the study according to the requirements of protocol;
- •Aged between 18 and 60 years old, both men and women;
- •Male ≥50kg, female ≥45kg,body mass index(BMI)=weight (kg)/height 2 (m2), BMI is 18-28 kg/m2 (including the critical value);
- •No mental abnormalities, no history of cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system or metabolic abnormalities;
- •Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, and imageological examination have no clinical significance;
- •The female blood pregnancy test is not pregnant, and the subjects (including male subjects) have no pregnancy plan and voluntarily take effective contraceptive measures from 2 weeks before administration to at least 3 months after the last use of the study drug. See the appendix for specific contraceptive measures.
排除标准
- •Previous disease of the neuropsychiatric system, respiratory system, cardiovascular system, digestive system, hemo-lymphatic system, liver and kidney dysfunction, endocrine system, musculoskeletal system, or other disease that the investigator determines may affect drug metabolism or safety;
- •Have a history of fainting needles, fainting blood;
- •Known allergy to Liraglutide and its metabolites or any of the excipients of the formulation;
- •Those who smoked more than 5 cigarettes per day during the 3 months before the trial.
- •History of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine);
- •Donated blood or lost a lot of blood (> 450 ml) within 2 months before taking the study drug ;
- •Have taken any drug that changes liver enzyme activity 28 days before taking the study drug (such as liver drug enzyme inhibitor chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver drug enzyme inducer barbital Drugs, carbamazepine, rifampicin, dexamethasone, etc.);
- •Have taken any prescription, over-the-counter, vitamin product or herbal medicine within 1 month prior to the use of the study drug;
- •During the trial it is necessary to use tobacco, alcohol, and caffeine-containing drinks, or certain foods that may affect metabolism (such as grapefruit, grapefruit juice, etc.), or major changes in diet or exercise habits before the test, or other effects that affect drug absorption, Factors such as distribution, metabolism, excretion, etc;
- •Have taken the study drug or participated in the drug clinical trial within 2 months before taking the study drug;
- •Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
- •Female subjects are breastfeeding or have a positive serum pregnancy result during the screening period or during the test;
- •Those who have been screened positive for drugs or have a history of drug abuse in the past five years or have used drugs in the 3 months before the trial;
- •Blood collection is difficult or cannot tolerate venipuncture blood collection;
- •Acute illness during the screening phase or before study medication;
- •The subject is unable or can not comply with ward management regulations;
- •The subject is unable to complete the study due to personal reasons;
- •Other cases judged by researchers to be unsuitable for selection.
研究组 & 干预措施
Liraglutide injection + Victoza
Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.
干预措施: Liraglutide injection (Drug)
Liraglutide injection + Victoza
Subjects receive liraglutide injection in the first cycle and Victoza in the second cycle.
干预措施: Victoza (Drug)
Victoza +Liraglutide injection
Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle.
干预措施: Liraglutide injection (Drug)
Victoza +Liraglutide injection
Subjects receive Victoza in the first cycle and liraglutide injection in the second cycle.
干预措施: Victoza (Drug)
结局指标
主要结局
Maximum (peak) plasma drug concentration(Cmax)
时间窗: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.
Maximum (peak) plasma drug concentration
Elimination half-life (t1/2)
时间窗: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
The time required for the highest concentration of the drug in plasma to decrease by half
Apparent volume of distribution after non-intravenous administration (Vd/F)
时间窗: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent volume of distribution
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
时间窗: 0 hour（pre-dose,within 60mins） to 72hours after administration on day1 and day 15.
Time to maximum concentration
Bioavailability (systemic availability of the administered dose)
时间窗: 0 hour（pre-dose, within 60mins） to 72 hours after administration on day1 and day 15.
Relative bioavailability
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
时间窗: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
The area under the plasma concentration curve from 0 to infinity
Terminal disposition rate constant/terminal rate constant (λz)
时间窗: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent end elimination rate constant
Apparent total clearance of the drug from plasma after oral administration (CL/F)
时间窗: 0 hour（pre-dose, within 60 mins） to 72 hours after administration on day1 and day 15.
Apparent total body clearance
Adverse Event, Serious Adverse Event and Drug Combination
时间窗: up to day 15
Monitor the safety indicators of subjects during the trial
次要结局
- clinical symptoms(From the screening period to day 18 after the first administration)
- The Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 (physical examination)(From the screening period to day 18 after the first administration)
- body temperature(1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15)
- pulse(1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15)
- blood pressure(1 hour before administration and 2 hours, 10 hours, 24 hours, 48 hours, 72 hours after administration on day 1 and day 15)
- The Number of participants with abnormal laboratory examinations(From the screening period to day 18 after the first administration)