Pharmacokinetic and Pharmacodynamic Bioequivalence of Single Dose Zydus pegfilgrastim to NeulastaÂ® pegfilgrastim from US and EU Sources - NI

Cadila Healthcare limited0 个研究点目标入组 90 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Provision of signed and dated written informed consent prior to any study specific procedures
•2.Willing and able to comply with the study procedures, restrictions and requirements
•3.At least (>=) 18 years of age and no more than (<=) 45 years of age at the time of signing informed consent
•4.Body mass index (BMI) >=19.0 and <=25.0 kg/m2 (inclusive) and a body weight of 50 to 100 kg (inclusive)
•5.In general good health as determined by an experienced physician based on a comprehensive medical history and physical examination. Minor abnormalities in laboratory testing are allowable if not contraindicated by this protocol, and if in the estimation of the Investigator, pose no additional risk to participation nor interference with study procedures

•1.Known hypersensitivity to Escherichia coli derived proteinsâ?? pegfilgrastimâ?? filgrastim or any other component of Zydus pegfilgrastim or NeulastaÂ®
•2.Hereditary problems with fructose intolerance and/or sorbitol
•3.Any prior exposure to any peptide colony stimulating or growth factor, including erythropoietin, filgrastim or pegfilgrastim; or prior immunoglobulin preparations within the past six months
•4.Positive standard drug as well as alcohol screen
•5.Blood donation in the past 3 months, or bone marrow or stem cell donor in the past 12 months

发起方