CTRI/2016/07/007117进行中（未招募）1 期
A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO-PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST BIOEQUIVALENCE BETWEEN TWO FORMULATIONS OF RECOMBINANT HUMAN INSULINS; WOSULIN R (200 IU) WITH WOSULIN R (100 IU) IN HEALTHY SUBJECTS.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- PD: AUC (GIR, 0-12h), and GIRmax
研究概览
简要总结
Study yet to be initiated
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 14.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Body Mass Index (BMI) between 18.0 and 27.0 kg/m2, (both inclusive) 2.Subjects with normal results of 2 hours Oral Glucose Tolerance Test (OGTT) performed at screening.
- •Considered generally healthy upon completion of medical history, physical examination, X-ray chest (PA view), ECG, and biochemical investigations.
排除标准
- •HbA1c values (at screening) more than 5.7%.
结局指标
主要结局
PD: AUC (GIR, 0-12h), and GIRmax
时间窗: PK: 12 hours | PD: 12 hours
PK: AUC0-12 and Cmax
时间窗: PK: 12 hours | PD: 12 hours
次要结局
- PK endpoints: AUC0-4h, AUC0-6h, AUC6-12h, AUC0- ï‚¥, tmax, t½ and elimination rate(constant (ï¬z))
研究者
研究点 (1)
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