CTRI/2010/091/001220已完成1 期
Open label, balanced, randomized, two-treatments, single-period, single-dose, parallel, comparative subcutaneous pharmacodynamic and pharmacokinetic study of peginterferon alpha 2 b 1 microgram/kg of m/s Cadila Healthcare Ltd., Ahmedabad, India with Viraferon Peg containing 1 microgram/kg peginterferon alpha 2 b of Schering Plough, Ireland in healthy, adult, male, human subjects
Cadila Healthcare Limited, Zydus Tower, Satellite Road, Ahmedabad, Gujarat0 个研究点目标入组 50 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
- 50
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
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 Peginterferon alpha 2 b or any other related drug.
- •2. Preexisting increase in Interferon response marker (baseline serum neopterin concentration).
- •3. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal.
- •4. Renal insufficiency (serum creatinine > 1.5 mg/dL).
- •5. History of depression necessitating hospitalisation, two or more recurrent episodes of depression, or suicide attempt.
- •6. History of epilepsy.
- •7. History or presence of blood dyscrasias (eg., thrombocytopenia, neutropenia).
- •8. History or presence of thyroid disorders.
- •9. History or presence of pulmonary disorders (eg., dyspnoea, pneumonia)
- •10. History or presence of autoimmune disorders (eg., thyroiditis, rheumatoid arthritis).
- •11. History or presence of arrhythmia or any other cardiovascular disease.
- •12. History or presence of eye disorders (e.g., retinal haemorrhage).
- •13. History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement).
- •14. Subjects taking drugs that have a narrow therapeutic index (e.g. anti-epileptics etc) and drugs that can depress the immune system (e.g. anti-cancer drugs etc).
- •15. History or presence of significant alcoholism or drug abuse within the past one-year.
- •16. History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products.
- •17. Difficulty with donating blood.
- •18. Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 mm Hg.
- •19. Pulse less than 60/minute or more than 100/minute.
- •20. Febrile.
- •21. Any ECG abnormalities.
- •22. Major illness during 3 months before the screening period
- •23. Subjects who have participated in drug research studies within past 3 months.
- •24. Subjects who have donated one unit (350ml) of blood in the past 3 months.
- •25. 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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