TCTR20210511002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 Erythropoietin-SBS 4000 IU, 0.4 ml in syringe subcutaneous injection relative to Hema-Plus 4000 prefilled syringes 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
- 24
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.Healthy Thai subjects are between 18 to 55 years of age
- •2.The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2
- •3.Healthy, no history of evidence of chronic disease or severe disorder
- •4.No history of usually smoking (more than 10 cigarettes per day within past 1 year)
- •5.No history of alcoholism (more than 2 years)
- •6.Negative pregnancy test for women and no breast-feeding
排除标准
- •1.History or evidence of allergy or hypersensitivity to Epoetin alfa or product derived from mammalian cells or human albumin or any related drugs or any of the excipients of this product
- •2.Subject with BP is Systolic BP below 85, from 130 mm/Hg and over; Diastolic BP below 60, from 90 mm/Hg and over; Pulse rate over 100 bpm
- •3.Serum bilirubin greater than 1.5 times ULRR
- •4.Serum creatinine greater than 1.5 times ULRR
- •5.Alanine amino transferase or aspartate amino transferase greater than 2 times 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, glaucoma, thrombotic vascular events, cerebrovascular accidents
- •9.History of epilepsy or seizures
- •10.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy
- •11.Any major illness in the past 3 months or any significant ongoing chronic medical illness
- •12.History of psychiatric disorder
- •13.History of regular alcohol consumption and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study
- •14.History of usually smoking, if moderate smokers cannot stop at least 7 days before the study drug administration and until the completion of each period of the study
- •15.High caffeine consumption and cannot stop at least 2 days before the study drug administration until the completion of each period of the study
- •16.Positive drug abused test in urine
- •17.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer)
- •18.History of difficulty in accessibility of veins in left and right arm
- •19.Blood donation within the past 3 months before the study
- •20.Participation in any clinical study within the past 3 months before the study
- •21.Subjects who are unwilling or unable to comply with this protocol
研究者
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