Study of the pharmacokinetic and pharmacodynamic and safety properties of Tinapeg® (6 mg/0.6 ml syringes, AryaTinaGene Biopharmaceutical Co) in comparison to Neulastim® (6 mg/0.6 ml syringes, Amgen) in healthy volunteers

AryaTinaGene Biopharmaceutical Co0 个研究点目标入组 24 人开始时间: 待定最近更新: 2018年11月5日

试验速览

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•Males, 18-50 years of age.
•The subject is able and willing to provide signed informed consent.
•The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent.
•The subject has stable residence and telephone.
•Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.

•History of allergy or sensitivity to pegfilgrastim.
•History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study.
•Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
•Presence of gastrointestinal disease or history of malabsorption within the last year.
•History of a medical disorders occurring within the last year that required hospitalization or medication
•Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to the present study.
•Receipt of any drug as part of a research study within 30 days prior to the present study.
•Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study.

发起方

AryaTinaGene Biopharmaceutical Co