KCT0000118已完成未知
A randomized, open-label, single-dosing, crossover study to compare the safety and pharmacokinetic characteristics of TuNEX injection 25 mg with those of Enbrel injection 25 mg after subcutaneous injection in healthy male volunteers
Bio Trion0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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 Study
入排标准
- 年龄范围
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1.Healthy male adults aged 20 ~ 55 at screening
- •2.No clinically significant congenital or chronic disease (if required, encephalography, electrocardiogram, thoracic or gastroendoscope or gastroradiography) or pathological symptoms
- •3.Judged to be healthy by the responsible doctor based on clinical laboratory test results such as a general blood test, serochemical test and urine test, etc.
- •4.Signed informed consent
- •5.Able to participate during the study period and conform to the study requirements
排除标准
- •1.Past or current medical history for the diseases in hepatobiliary, renal, nervous, hematologic or cardiovascular systems including oncologic diseases.
- •2.Clinically significant history or current hypersensitivity to pharmaceutical containing an ingredient of the test or reference drugor other relevant pharmaceuticals (aspirin, antibiotics, etc.)
- •3.Either a systolic B.P. = 90 mmHg or diastolic B.P. = 50 mmHg” or systolic B.P. = 150 mmHg or diastolic B.P. = 100 mmHg” at measurement in the sitting position after over 3 min rest.
- •4.Septicemia or the risk of it
- •5.Active infection (chronic or local) including tuberculosis
- •6.A history of drug abuse or a positive result on urine drug testing
- •7.Used any drug metabolic enzyme inducer or inhibitior such as barbituates or drank excessive alcohol within 1 month prior to study initiation
- •8.Administered any prescription drug or herbal medicine within 2 weeks prior to the first administration day, or administered any over-the-counter drug or vitamin agent within 1 week before the first administration (however, such a subject can be included when investigators so determined after considering other conditions)
- •9.Participated in another clinical study within 2 months prior to first administration
- •10.Donated whole blood within 2 months prior to the first administration, apheresis within 1 month prior to the first administration or treated with transfusion within 1 month prior to first administration
- •11.Chronic alcohol consumer (over 21 units/week, 1 unit = 10 g of pure alcohol) or inable to stop drinking during the study
- •12.Determined to be inappropriate for the study based on laboratory tests or other reasons
研究者
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