NCT01401244已完成1 期
A Trial to Examine the Bioequivalence of Norditropin® Versus Genotropin® in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum observed serum hGH concentration
研究概览
简要总结
This trial is conducted in United States of America (USA). The aim of this trial is to examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) 18.0-27.0 kg/m^2 (both inclusive)
- •Considered generally healthy upon completion of medical history, physical examination, vital signs, screening laboratory results, and electrocardiogram (ECG), as judged by the Investigator (trial physician)
排除标准
- •The receipt of any investigational medicinal product within 1 month prior to this trial
- •Current or previous treatment with growth hormone or IGF-I (insulin-like growth factor-I)
- •Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) for the duration of the trial
- •Known presence or history of malignancy
- •Diabetes mellitus
- •Use of pharmacologic doses of glucocorticoids
- •Use of anabolic steroids
- •History of drug or alcohol abuse
研究组 & 干预措施
Norditropin®
Experimental
干预措施: somatropin (Drug)
Genotropin®
Active Comparator
干预措施: somatropin (Drug)
结局指标
主要结局
Maximum observed serum hGH concentration
时间窗: over a 24-hour sampling period
Area under the serum hGH (human growth hormone) concentration-time curve
时间窗: from 0 to the time of the last quantifiable concentration over a 24-hour sampling period
次要结局
- The frequency of injection site reaction(from the time of injection of the trial product (day 1 and 13, respectively) to follow-up during the two dosing periods (day 5 and 17, respectively))
- The frequency of adverse events (AE)(from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product))
- Abnormal biochemistry laboratory parameters(from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product))
- Abnormal findings in physical examinations(from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product))
- Maximum IGF-I effect (Emax)(over a 96-hour sampling period)
- Area under the effect (IGF-I) curve(from time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period)
- Abnormal hematology laboratory parameters(from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product))
- Vital signs(from screening (3-14 days before first dose of trial product) to follow-up period (day 17 after first dose of trial product))
研究者
研究点 (1)
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