IRCT2016033021315N4已完成1 期
A randomised, double-blind, single-dose, active-controlled,crossover study in healthy subjects todemonstrate pharmacokinetic equivalence ofAltebrelTM (produced by AryoGen Pharmed) and Enbrel:registered:(produced by Amgen Company)
AryoGen Pharmed Company0 个研究点目标入组 34 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
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
- Male
入选标准
- •1)Provide written IC to participate in the trial and to comply with the trial procedures.
- •2)Take written informed consent to participate in the trial and to abide by the trial restrictions.
- •3)Be healthy male between the ages of 18 and 55 years. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.
- •4)Have a body mass index between 20.0 and 30 kg/m², inclusive
- •5)Have Chest X-ray with no evidence of current, active TB or previous (inactive) TB, general infections, heart failure, malignancy, or other clinically significant abnormalities taken at Screening or within 24 weeks prior to Day 1 and read by a qualified radiologist.
- •1.Being doubtful about their availability to complete the trial.
- •2.history and/or current presence of clinical significant atopic allergy, hypersensitivity or allergic reactions, also including known or suspected clinically relevant drug hypersensitivity to any components of the test and reference IMP formulation or comparable drugs.
- •3.Active or latent Tuberculosis or who have a history of Tuberculosis.
- •4.history of invasive systemic fungal infections or other opportunistic infections
- •5.systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process
- •6.serious infection associated with hospitalisation and/or which required intravenous antibiotics
- •7.history of and/or current cardiac disease
- •8.Have received live vaccine(s) within 30 days prior to Screening or who will require live vaccine(s) between Screening and the final study visit.
- •9.Intake medication with a half-life > 24 h within 1 month or 5 half-lives of the medication prior to the first administration of IMP.
- •10.Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody. A positive test for HIV antibody.
- •11.History of CNS demyelinating disorders in family (MS)
- •12.Have a history of smoking >10 cigarettes per day
排除标准
- 未提供
研究者
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