ACTRN12612000920897已完成1 期
A Double-blind, Randomised, Controlled, 3 Cohort, Dose ranging, Crossover, Pharmacokinetic and Pharmacodynamic Study of Two Preparations of Pegfilgrastim in Healthy Subjects
Dr. Reddy’s Laboratories (DRL)0 个研究点目标入组 36 人开始时间: 2012年8月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Healthy male and female subjects
- •- In general good health
- •-Must have normal organ function; including normal liver and renal function
- •-Non-smokers or ex-smokers who have not smoked within the previous 6 months from Screening visit.
- •-Subjects must be able to understand and willing to comply with the study procedures, restrictions and requirements as judged by the investigator.
排除标准
- •- Known hypersensitivity to Escherichia coli derived proteins and/or hypersensitivity to the study drug pegfilgrastim or filgrastim or any of its ingredients.
- •- History of hypersensitivity to latex.
- •- Any prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or pegfilgrastim; or prior immunoglobulin preparations within the previous 6 months from Screening visit.
- •Hereditary fructose intolerance.
- •- Any clinically significant laboratory findings (haematology, biochemistry and urinalysis) outside the normal laboratory range of the test laboratory (where the test will be conducted).
- •- Any psychological, familial, sociological, personal (including out of town trips) or geographical conditions that do not permit compliance with the Clinical Study Protocol.
- •- Hypertension, significant hypercholesterolemia as judged by the investigator, or thyroid abnormalities.
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