A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- AUCins.0-12h
研究概览
简要总结
Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin aspart preparations
To evaluate the single dose safety and local tolerability of the three insulin aspart preparations
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent obtained before any trial-related activities. Trial-related activities are any procedures that would not have been done during normal management of the subject
- •Healthy male subjects
- •Age between 18 and 64 years, both inclusive
- •Body Mass Index (BMI) between 18.5 and 29.0 kg/m^2, both inclusive
- •Fasting plasma glucose concentration <= 5.50 mmol/L (100 mg/dL) at screening
- •Considered generally healthy upon completion of medical history, physical examination, vital signs, ECG and analysis of laboratory safety variables, as judged by the Investigator
排除标准
- •Known or suspected hypersensitivity to investigational medicinal products (IMPs) or related product
- •Previous participation in this trial. Participation is defined as randomized
- •Use of other investigational drugs within five half-lives for enrolment or receipt of any medicinal product in clinical development within 30 days before randomization in this trial, whichever is longer
- •History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
- •Clinically significant abnormal values for haematology, biochemistry, coagulation, or urinalysis as judged by the Investigator
- •Increased risk of thrombosis, e.g subjects with a history of deep leg vein thrombosis or family history of deep leg vein thrombosis, as judged by the Investigator
- •A positive result in the alcohol and/or urine drug screen at the screening visit
- •Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen
- •Blood donation or blood loss of m ore than 500 mL within the last 3 months
研究组 & 干预措施
Gan & Lee Insulin Aspart
100 units/mL, 3 ml prefilled pen
干预措施: Gan & Lee Insulin Aspart (Drug)
NovoRapid® Insulin Aspart
Product approved and marketed in the EU
FlexPen100 units/mL prefilled pen
干预措施: Gan & Lee Insulin Aspart (Drug)
NovoLog® Insulin Aspart
Product approved and marketed in the US
FlexPen100 units/mL prefilled pen
干预措施: Gan & Lee Insulin Aspart (Drug)
结局指标
主要结局
AUCins.0-12h
时间窗: 0 -12 hours
PK endpoint: The area under the insulin concentration curve from 0 to 12 hours
Cins.max
时间窗: 0 -12 hours
PK endpoint: The maximum observed insulin concentration
AUCGIR.0-12h
时间窗: 0 - 12 hours
PD endpoint: The area under the glucose infusion rate curve from 0 to 12 hours
GIRmax
时间窗: 0 - 12 hours
PD endpoint: The maximum glucose infusion rate
次要结局
- AUCins.0-2h(0 - 2 hours)
- AUCins.0-∞(0 - 12 hours)
- tins.max(Up to Day 68)
- t50%-ins(early)(Up to Day 68)
- t50%-ins(late)(Up to Day 68)
- t½(Up to Day 68)
- λz(Up to Day 68)
- AUCGIR.0-2h(0 - 2 hours)
- tGIR.max(Up to Day 68)
- tGIR.50%-early(Up to Day 68)
- tGIR.50%-late(Up to Day 68)
- PD endpoint(Up to Day 68)
- Safety and local tolerability(Up to Day 68)