NCT00938678已完成1 期
A Phase I, Randomized, Single Dose, Crossover Study Evaluating the Pharmacokinetics and Pharmacodynamics of Pegfilgrastim Hospira Compared to Neulasta (Amgen) Following Subcutaneous Administration to Healthy Volunteers
Hospira, now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Area under the curve from time 0 extrapolated to infinity (AUC0-∞) for serum Pegfilgrastim (PEG-GCSF)
研究概览
简要总结
This study compared the pharmacokinetics, pharmacodynamics and the safety of Pegfilgrastim Hospira and Neulasta® following a single dose of 6 mg of each product administered subcutaneously in Treatment Periods 1 and 2, respectively, in healthy volunteers.
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
- None
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 female subjects, 18-55 years inclusive.
- •Written informed consent given
- •Willing and able to comply with the requirements of the protocol and be available for the planned duration of the study.
- •Body Mass Index (BMI) between 19 and 30 kg/m2 inclusive and weight not <50 kg or >100 kg.
- •Female subjects who are using an effective method of contraception, or are surgically sterile.
- •Non-smokers or ex-smokers who have not smoked within the previous 12 months.
排除标准
- •Hypersensitivity to the Investigational medicinal product (IMP) or its constituents and/or hypersensitivity to E. Coli derived proteins, and/or previous exposure to the IMP.
- •History or presence of any clinically significant findings that, in the opinion of the Investigator, would preclude inclusion in the study.
- •History or presence of any clinically significant gastrointestinal pathology or symptoms, liver or kidney disease, or any other condition that might interfere with the absorption, distribution, metabolism or excretion of the drug.
- •Any clinically significant laboratory findings, including any ANC, platelet or haemoglobin result outside the reference range of the local laboratory.
- •Abnormal vital signs or abnormal 12-lead electrocardiogram (ECG) results, as judged by the Investigator to be clinically significant.
- •Females, pregnant or lactating, or planning to become pregnant during the time the subject is on study.
- •Subjects with a history of pulmonary infiltrate or pneumonia in the previous 6 months from the date of the screening visit.
- •Hereditary fructose intolerance.
- •Participation in any other clinical trial using a investigational product or device, within the previous 12 weeks from the date of the screening visit.
- •Positive result for human immunodeficiency virus (HIV) and/or hepatitis B and C tests.
- •Evidence of, or treatment for, drug or alcohol abuse within one year from date of screening visit.
- •Blood donation >=500 mL in the previous 12 weeks from the date of the screening visit.
- •Use of any prescription medication (excluding hormonal contraceptives) within 14 days prior to date of the screening visit.
- •Receipt of over-the-counter medicines which have not yet cleared from the body (five half-lives must have passed for the medicine to be considered to have cleared from the body). Vitamins, minerals and nutritional supplements may be taken at the discretion of the Investigator.
研究组 & 干预措施
Treatment Group 1
Experimental
干预措施: Pegfilgrastim Hospira (Drug)
Treatment Group 2
Active Comparator
干预措施: Neulasta (Amgen) (Drug)
结局指标
主要结局
Area under the curve from time 0 extrapolated to infinity (AUC0-∞) for serum Pegfilgrastim (PEG-GCSF)
时间窗: Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.
Area under the curve from time 0 to the last time point (AUC0-t) for serum Pegfilgrastim (PEG-GCSF)
时间窗: Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.
AUC0-t will be used as a primary parameter only if AUC0-∞ cannot be calculated for all subjects in the pharmacokinetic population.
Pharmacodynamics: Maximum change from baseline in absolute neutrophil count (ANC); ANC_Cmax
时间窗: Screening, Day -1, Treatment Periods 1 & 2: Pre-dose (-60 min, -30 min, 0 min), Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2)
次要结局
- Time to maximum concentration (Tmax) for serum Pegfilgrastim (PEG-GCSF)(Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.)
- Maximum concentration (Cmax) for serum Pegfilgrastim (PEG-GCSF)(Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.)
- Terminal elimination rate constant (λz) for serum Pegfilgrastim (PEG-GCSF)(Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.)
- Time of maximum change from baseline for ANC in days (ANC_Tmax)(Screening, Day -1, Treatment Periods 1 & 2: Pre-dose (-60 min, -30 min, 0 min), Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2))
- Half-life (T½) for serum Pegfilgrastim (PEG-GCSF)(Treatment Periods 1 and 2: Pre-dose (-15 min) and post-dose 1, 2, 4, 6, 8, 10, 16, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2 hours or early discontinuation.)
- Area under the curve above baseline of ANC [ANC_AUC(0-tlast)](Screening, Day -1, Treatment Periods 1 & 2: Pre-dose (-60 min, -30 min, 0 min), Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2, 264±2, 288±2))
- Maximum change from baseline in CD34+ count (CD34+_Cmax)(Day -1, Treatment Periods 1 & 2: Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2))
- Time of maximum change from baseline for CD34+ count in days (CD34+_Tmax)(Day -1, Treatment Periods 1 & 2: Post dose (12 hr, 24±2, 48±2, 72±2, 96±2, 120±2, 144±2, 168±2, 192±2, 216±2, 240±2))
研究者
研究点 (1)
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