A Trial to Examine the Bioequivalence of Norditropin® Versus Nutropin AQ® in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)
研究概览
简要总结
This trial is conducted in Europe and United States of America (USA). The aim of this trial is to examine the bioequivalence (assessment of the expected biological equivalence of two pharmaceutical drug products with identical active ingredient) of Norditropin® versus Nutropin AQ® 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
- •No previous exposure to recombinant human GH (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 recombinant human 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) 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®
干预措施: somatropin (Drug)
Nutropin AQ®
干预措施: somatropin (Drug)
结局指标
主要结局
Area under the serum hGH (human growth hormone) concentration-time curve (AUC0-t)
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) curve from time 0 to the time of the last concentration (AUEC0-t)
时间窗: Over a 96-hour sampling period
Maximum IGF-I (insulin-like growth factor-I) effect (Emax)
时间窗: Over a 96-hour sampling period
次要结局
- The frequency of adverse events (AE) and vital signs(From screening (14 days before randomisation) to follow-up period (3-21 days after randomisation))
- The frequency of abnormal hematology(From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation))
- The frequency of abnormal findings in physical examinations(From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation))
- Biochemistry laboratory parameters(From screening (14 days before randomisation) to follow-up period (20-23 days after randomisation))
- The frequency of injection site reaction(From the time of injection of the trial product (day 1 and day 13) to follow-up during the two dosing periods (day 5 and day 17))
- Area under the effect (IGFBP-3) curve(From time 0 to the time of the last concentration (AUEC0-t) over a 96-hour sampling period)
- Maximum IGFBP-3 (insulin-like growth factor binding protein 3) effect (Emax)(Over a 96-hour sampling period)