A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin N and Humulin® N
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Primary PK endpoint: maximum observed insulin concentration(Cins.max)
研究概览
简要总结
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
详细描述
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin N with Humulin® N in healthy subjects.
The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 17 to 43 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration).
Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.
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
- Double (Participant, Investigator)
盲法说明
Double blind study
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and post-menopausal female subjects. Post-menopausal defined as 12 months of no menses without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (>= 25.8 IU/L).
- •Age between 18 and 55 years, both inclusive
- •Body mass index between 18.5 and 29.0 kg/m^2, both inclusive.
- •Fasting plasma glucose concentration <= 100 mg/dl.
- •Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.
排除标准
- •Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
- •Systolic blood pressure < 95 mmHg or >140 mmHg and/or diastolic blood pressure < 50 mm Hg or >90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
- •Pulse rate at rest outside the range of 50-90 beats per minute.
- •Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
结局指标
主要结局
Primary PK endpoint: maximum observed insulin concentration(Cins.max)
时间窗: 0-24hour
maximum observed insulin concentration
Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h
时间窗: 0-24hour
area under the insulin concentration curve
PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h
时间窗: 0-24hour
area under the glucose infusion rate curve
PD endpoint:maximum observed glucose infusion rate (GIRmax)
时间窗: 0-24hour
maximum observed glucose infusion rate
次要结局
- Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h(12-24hour)
- Secondary PK endpoint: time(t)50%-INS(late)(0-24 hours)
- Secondary PD endpoint: Onset of action(0-24 hours)
- Secondary PK endpoint: terminal elimination half-life (t½)(0-24 hours)
- Secondary PK endpoint: time(t)50%-INS(early)(0-24 hours)
- Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h(12-24hours)
- Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-infinity(0-24 hours)
- Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h(0-12hour)
- Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins)(0-24 hours)
- Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR)(0-24 hours)
- Secondary PD endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early)(0-24 hours)
- Secondary PD endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)(0-24 hours)
- Secondary PK endpoint:terminal elimination rate constant of insulin (λz)(0-24 hours)
- Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h(0-12hours)