CTRI/2013/04/003578尚未招募未知
Pharmacokinetic and Pharmacodynamic Bioequivalence of Single Dose Zydus pegfilgrastim to Neulasta® pegfilgrastim from US and EU Sources
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •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
- •6.Adequate organ function as determined by Chest X-ray and laboratory assessments within the institutional normal range including the following parameters: hematology (adequate iron stores [transferrin saturation >=15%]; mean corpuscular volume (MCV), total iron binding capacity, platelets, vitamin B12 and folate), serum chemistry and serology
- •7.Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening
- •8.Subjects who are negative for drugs of abuse and alcohol tests at screening and admission to each study period
- •9.Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the first day of study medication administration until 3 months after receiving the last administration of study medication
排除标准
- •1.Known hypersensitivity to Escherichia coli derived proteinsâ?? pegfilgrastimâ?? filgrastim or any other component of Zydus pegfilgrastim or Neulasta®
- •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
- •6.A history or evidence of drug or alcohol abuse (CAGE criteria) or smoking history (except non-smoker for at least 1 year and should not have been a moderate/heavy smoker [ie, 10 cigarettes or more per day])
- •7.History of unexplained syncopal or hypotensive episodes
- •8.Any disorder that, in the Investigatorâ??s opinion, may interfere with study compliance, such as significant mental or nervous disorder or other illness. In making this assessment, the Investigator must refer to the study information provided including the Investigatorâ??s Brochure, and the prescribing information for Neulasta® and Zydus pegfilgrastim
- •9.Has participated in an interventional or Phase I study in the last 3 months or is currently on a follow-up visit schedule for any study, or has participated in more than three studies of experimental drug products in the past 12 months
- •10.Any clinically significant laboratory findings, including CD34+, platelet or hemoglobin, WBC count and differential results outside the normal laboratory ranges at screening or on Day -1 of Period 1
- •11.Subjects with ANC values outside the normal laboratory range at screening and on Day -1 of Period 1
- •12.History of any hematologic disease as well as sickle cell disorders
- •13.History of any cancer, including carcinoma in situ
- •14.Currently receiving or planning to receive steroids either parenterally, by mouth or via inhalation
- •15.Major surgery within the past year or major surgery planned within 3 months of study enrolment
- •16.Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
- •17.Inability to be venipunctured and/or tolerate venous puncture
- •18.Blood pressure decrease of at least 10 mmHg within 3 minutes of standing up to exclude any orthostatic hypotension
- •19.Any condition/ abnormal baseline findings that in the Investigatorâ??s judgement might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to obtain the objective of the study
- •20.Has a significant infection or known inflammatory process on screening or within 2 weeks of admission to the study center on Day -1 of Period 1
- •21.Has acute gastrointestinal symptoms at the time of screening or admission (eg, nausea, vomiting, diarrhea, heartburn)
- •22.Has an acute infection such as influenza at the time of screening or admission
- •23.Has used prescription drugs within 4 weeks of first dosing
- •24.Has used over the counter medication excluding routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as not clinically relevant by the Investigator and Sponsor
研究者
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