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
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To compare the pharmacokinetic and pharmacodynamic behavior of Interferon beta 1 b 0.5 mg of Cadila healthcare Ltd, India with Betaferon 0.5 mg of Schering (Pvt) Ltd, Germany inhealthy human subjects.To monitor the safety and tolerability of Interferon beta 1 b in healthy human subjects.
研究概览
简要总结
This is an 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. The objective of this study is to compare the PK/PD behaviour of interferon beta 1 b 0.5 mg of Cadila healthcare Ltd.,India with betaferon 0.5 mg of Schering Ltd.,Germany and to monitor the safety and tolerability of Interferon beta 1 b in healthy human subjects. A total of 28 adult, male, human subjects will be enrolled in this study and analysed for pharmacokinetic and pharmacodynamic study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
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.
结局指标
主要结局
To compare the pharmacokinetic and pharmacodynamic behavior of Interferon beta 1 b 0.5 mg of Cadila healthcare Ltd, India with Betaferon 0.5 mg of Schering (Pvt) Ltd, Germany inhealthy human subjects.To monitor the safety and tolerability of Interferon beta 1 b in healthy human subjects.
时间窗: For PK Analysis: The venous blood samples will be withdrawn at pre-dose and at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 12.00,16.00, 24.00, 36.00 and 48.00 hours following drug administration.For PD Analysis: The venous blood samples will be collected at predose and at 0.50,1.00, 2.00, 3.00, 4.00, 6.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00, and 168.00 hours following drug administration.Clinic al Safety Measures: Vital signs like sitting blood pressure and radial pulse will be measured and recorded during subject check-in, prior toadministration of dose, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00,12.00, 24.00 and 36.00 hours after the administration of dose and at checkout.
次要结局
未报告次要终点