RBR-6wdrhw尚未招募1 期
Phase I Clinical Study with Pharmacokinetic and Pharmacodynamic Determination of Pegfilgrastim for Subcutaneous Use in Healthy Participants.
CAEP - Centro Avançado de Estudos e Pesquisas0 个研究点开始时间: 2018年10月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- 18Y 至 55Y（—）
入选标准
- •Sign the TCLE approved by the CEP; Participants of both sexes between the ages of 18 and 55; Participant must be physically and mentally healthy through information collected from medical history, general physical examination and vital signs, laboratory tests and electrocardiogram not indicating any evidence of disease; Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 29.9 kg / m2.
排除标准
- •Diagnosis of malignant disease in the last 5 years, except for successful basal cell carcinoma; Prior diagnosis of severe asthma, sickle-cell anemia or anaphylaxis; Laboratory alteration (at the discretion of the researcher) of any nature that could compromise participation in the study; Use of legal or illegal drugs; Hypersensitivity or contraindication of use to the components of the medications studied; Participation in another clinical study in a period of less than 1 year (unless justified by the researcher); Women of childbearing age without adequate contraception, pregnant or breastfeeding; Blood donation (greater than 500 mL) in the preceding 3 (three) months.
研究者
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