CTRI/2011/12/002221已完成未知
Open label,balanced,randomized,two-treatments,single-dose,parallel,comparative subcutaneous pharmacokinetic and pharmacodynamic study of Interferon Beta 1 b 0.5 mg of M/S Cadila Healthcare Ltd.,Ahmedabad,India with Betaferon containing 0.5 mg Interferon Beta 1 b of Schering(PTY) Ltd, Germany in healthy, adult, male, human subjects.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 28
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.Male subjects aged between 18 and 45 years (including both).
- •2.Subjects weight within ±15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
- •3.Ability to communicate effectively with study personnel.
- •4.Willingness to adhere to the protocol requirements.
- •5.Able to give consent for participation in the trial.
- •6.Normal health as determined by personal medical history, clinical examination, and laboratory examinations data during screening(within the clinically acceptable range )
排除标准
- •1.History of hypersensitivity to Interferon beta 1 b or any other related drug or preexisting increase in Interferon response marker (baseline serum neopterin concentration)
- •2.Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal or renal insufficiency (serum creatinine 1.5 mg/dL).
- •3.History of depression necessitating hospitalisation, two or more recurrent episodes of depression, or suicide attempt.
- •4.History or presence of epilepsy or blood dyscrasias (eg., lyphocytopenia, neutropenia) , thyroid disorders, cardiomyopathy or any other cardiovascular disease, musculo-skeletal disorders (e.g., myopathies, myolysis, etc.), other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).
- •5.Subjects taking drugs that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics, oral anticoagulants etc.
- •6.History or presence of significant alcoholism or drug abuse within the past one-year or significant smoking (more than 10 cigarettes per day) or consumption of tobacco products or difficulty with donating blood.
- •7.Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 mm Hg or pulse less than 60/minute or more than 100/minute.
- •8.Febrile or any ECG or X-ray abnormalities during screening, major illness during 3 months before the screening period, presence of clinically significant abnormal laboratory values during screening.
- •9.Subjects who have participated in drug research studies within past 3 months.
- •10.Subjects who have donated one unit (350ml) of blood in the past 3 months.
- •11.Subjects who are found positive in alcohol breath test and urine test for drug of abuse at the time of check in.
研究者
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