TCTR20211222007尚未招募1 期
A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Filgrastim-SBS 300 mcg/0.5 mL subcutaneous injection relative to Neupogen 300 mcg/0.5 mL subcutaneous injection in healthy Thai volunteers under fasting condition
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1.Willingness to provide written informed consent prior to participate in the study.
- •2.Healthy Thai subjects are between 18 to 55 years of age.
- •3.The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2.
- •4.Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects safety after the completion of the study.
- •5.Negative urine pregnancy test for women and no breast-feeding.
- •6.Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Some of the laboratory values e.g. Complete blood count etc. that out of the normal range will be carefully considered by physician.
排除标准
- •1.History or evidence of allergy or hypersensitivity to Filgrastim or E. coli-derived proteins or any related drugs or any of the excipients of this product.
- •2.Subject with B.P. is Systolic B.P <90, >=140 mm/Hg, Diastolic B.P <60, >=90 mm/Hg, pulse rate >100 beats per minute.
- •3.Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
- •4.Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
- •5.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
- •6.Positive of hepatitis B or C virus.
- •7.Have more than one abnormal EKG, which is considered as clinically significant. *
- •8.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, or glaucoma.
- •9.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
- •10.History of psychiatric disorder.
- •11.History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- •12.History of usually smoking (more than 10 cigarettes per day within past 1 year), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of each period of the study.
- •13.High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study.
- •14.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Methamphetamine, Cocaine and Opioids).
- •15.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-ProveraTM must be discontinued at least 6 months) prior to receiving the first dose of study medication.
- •16.History of difficulty in accessibility of veins in left and right arm.
- •17.Blood donation (one unit or 450 mL) within the past 3 months before the study.
- •18.Participation in any clinical study within the past 3 months before the study.
- •19.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
- •(* Depend on decision of principal investigator and/or clinical investigator)
研究者
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