A Trial to Investigate the Bioequivalence of Norditropin® (Somatropin) Versus Genotropin® (Somatropin) in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the serum hGH (human growth hormone) concentration-time curve
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the bioequivalence (the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® (somatropin) versus Genotropin® (somatropin) in healthy adult subjects.
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
- 是
入选标准
- •Healthy subjects at trial entry with no previous exposure to recombinant human growth hormone or IGF-I (insulin-like growth factor-I)
- •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
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
- •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 systemic corticosteroids
- •Use of anabolic steroids
- •History of drug or alcohol abuse
研究组 & 干预措施
Norditropin®
干预措施: Norditropin® FlexPro® pen (Drug)
Genotropin®
干预措施: Genotropin Pen® (Drug)
结局指标
主要结局
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.
Maximum observed serum hGH concentration
时间窗: Over a 24-hour sampling period
Area under the effect (IGF-I) (insulin-like growth factor-I) curve
时间窗: From time 0 to the time of the last measurable concentration (AUEC0-t) (area under the effect curve) over a 96-hour sampling period
Maximum IGF-I effect (Emax)
时间窗: Over a 96-hour sampling period
次要结局
- Abnormal haematology laboratory parameters(From screening to follow-up period (up to day 23))
- Abnormal biochemistry laboratory parameters(From screening to follow-up period (up to day 23))
- The frequency of injection-site reactions(From the time of injection of the trial product to follow-up during the 2 dosing periods (on Days 1 through 5, with visit 7 as follow-up and separately on Days 13 through 17, with visit 12 as follow-up for each period))
- Area under the effect (IGFBP-3) (insulin-like growth factor binding protein 3) curve(From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period)
- Maximum IGFBP-3 effect (Emax)(Over a 96-hour sampling period)
- The frequency of adverse events (AE)(From screening to follow-up period (up to day 23))
- Abnormal findings in vital signs(From screening to follow-up period (up to day 23))
- Abnormal findings in physical examinations(From screening to follow-up period (up to day)