A Randomized, Open-label, Two-period, and Double-cross Comparative Study on the Pharmacokinetics of Liraglutide Injection (RD12014) and Victoza® in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 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 pharmacokinetics similarity between the liraglutide injection (RD12014) produced by Sunshine Lake Pharma Co., Ltd. and liraglutide injection (Victoza®) produced by Novo Nordisk Pharmaceutical Co., Ltd for single dose in healthy male subjects, as well as to evaluate the similarity of the safety and immunogenicity between RD12014 and 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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Being willing to participate in the experiment, fully understand and sign the informed consent, fully understand and able to complete the experiment according to the requirements of the experiment protocol;
- •Aged between 18 and 45 years old of healthy male subjects ;
- •Weight ≥50kg, and body mass index(BMI)= 19.0-26.0 kg/m2 ;
- •No history of respiratory system, cardiovascular system, digestive system, urinary system, hematological system, endocrine system,nervous system or metabolic abnormalities;
- •Normal or abnormal vital signs, physical examination, laboratory examination, electrocardiogram, abdominal ultrasound examination and chest X-ray examination have no clinical significance;
排除标准
- •Have a history of fainting needles, fainting blood;
- •Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening;
- •Have taken any prescription, over-the-counter, herbal medicine or health care products (other than normal vitamin products)within 2 weeks prior to the use of the study drug;
- •Have a history of taken Liraglutide or other human glucagon-like peptides-1 analogues before the trial;
- •Those who have been screened positive for drugs at screening;
- •Donated blood (> 400 ml) within 3 months before taking the study drug;
- •Heavy smoker or those who smoked more than 10 cigarettes per day before taking the study drug.
- •Alcohol abuse (drinking 21 units of alcohol per week: 1 unit = 360 ml of beer or 45 ml of 40% alcoholic spirits or 150 ml of wine) or positive for breath alcohol test ;
- •Those who have been screened positive for drugs or have a history of drug abuse;
- •Known allergy to Liraglutide or any of the excipients of the formulation;
- •Those who have a history or family history of medullary thyroid cancer (grandparents, parents and siblings), or inherited diseases that predispose them to medullary thyroid cancer;Or have a history or family history of multiple endocrine adenomatosis;
- •Have participated in the drug clinical trial and taken the test drug within 3 months before taking the study drug;
- •During the trial period and within 3 months after the last dose, those who want their female partners to become pregnant or is unwilling to use reliable contraceptive methods
- •Other cases judged by researchers to be unsuitable for selection.
研究组 & 干预措施
Liraglutide injection (RD12014)+ Victoza
Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.
干预措施: Liraglutide injection,Victoza (Drug)
Victoza + Liraglutide injection (RD12014)
Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.
干预措施: Liraglutide injection,RD12014 (Drug)
Liraglutide injection (RD12014)+ Victoza
Subjects receive liraglutide injection(RD12014) in the first cycle and Victoza in the second cycle.
干预措施: Liraglutide injection,RD12014 (Drug)
Victoza + Liraglutide injection (RD12014)
Subjects receive Victoza in the first cycle and liraglutide injection(RD12014) in the second cycle.
干预措施: Liraglutide injection,Victoza (Drug)
结局指标
主要结局
Maximum (peak) plasma drug concentration(Cmax)
时间窗: 0 hour（pre-dose,within 30mins） to 72 hours after administration
Maximum (peak) plasma drug concentration
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
时间窗: 0 hour（pre-dose,within 30mins） to 72 hours after administration
The area under the plasma concentration curve from 0 to 72 h
次要结局
- Area under the plasma concentration-time curve from time zero to ∞ (AUC0-∞)(0 hour（pre-dose,within 30mins） to infinity after administration)
- Adverse Event, Serious Adverse Event(Up to day 4 after the second dose.)
- Apparent total body clearance (CL/F)(0 hour（pre-dose,within 30mins） to 72 hours after administration)
- Elimination half-life (t1/2)(0 hour（pre-dose,within 30mins） to 72 hours after administration)
- Time to reach maximum plasma concentration following drug administration (Tmax)(0 hour（pre-dose,within 30mins） to 72 hours after administration)
- Apparent volume of distribution (Vd/F)(0 hour（pre-dose,within 30mins） to 72 hours after administration)