A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h
研究概览
简要总结
Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects
详细描述
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin R with Humulin® R in healthy subjects.
The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 5-7 days between each dosing.
The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 12-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
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 or post-menopausal female subject. Post-menopausal state is defined as no menses for 12 months 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 (BMI) 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.
- •Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation in this trial.
- •Any history or presence of clinically relevant comorbidity, as judged by the investigator.
- •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.
结局指标
主要结局
PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h
时间窗: 0-12 hours
Area under the glucose infusion rate curve
PD endpoints:maximum glucose infusion rate(GIRmax)
时间窗: 0-12 hours
maximum glucose infusion rate
PK endpoints:Area under the insulin concentration curve(AUCins).0-12h
时间窗: 0-12 hours
Area under the insulin concentration curve from 0 to 12 hours.
PK endpoints: Maximum observed insulin concentration(Cins.max)
时间窗: 0-12 hours
Maximum observed insulin concentration
次要结局
- PK endpoint- time(t)50%-ins(late)(0-12 hours)
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-2h(0 to 2 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).0-2h(0 to 2 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).0-6h(0 to 6 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity(0 hours to 24 hours)
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).6-12h(6 to 12 hours)
- PK endpoint- Area under the insulin concentration curve(AUCins).6-12h(6 to 12 hours)
- PK endpoint- time(t)50%-ins(early)(0-12 hours)
- PK endpoint- terminal elimination half-life (t½)(0-12 hours)
- PD endpoint: time to maximum glucose infusion rate (tGIR.max)(0-12 hours)
- PD endpoint: time to half-maximum glucose infusion rate before GIRmax (tGIR,50%-early(0-12 hours)
- PK endpoint- time to maximum concentration( tmax)(0-12 hours)
- PK endpoint- terminal elimination rate constant (λz)(0-12 hours)
- PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-6h(0 to 6 hours)
- PD endpoint:time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)(0-12 hours)
- PD endpoint: Onset of action(0-12 hours)