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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Peak serum concentration (Cmax), time to reach peak serumconcentration (Tmax), area under serum concentration vs. time curve till the last time point (AUC0-t), area under serum concentration vs. time curve extrapolated to the infinity (AUC0-infinity), the residual area in percentage (AUC_% Extrap), serum elimination half-life (t1/2), elimination rate constant
研究概览
简要总结
Peginterferon alpha 2 b injection formulation is being developed by M/s. Cadila Healthcare Ltd. This study is being conducted to evaluate the pharmacodynamics and pharmacokinetics of the product of Cadila Healthcare Ltd. in comparison to the existing formulation of Schering Plough, Ireland. And also to evaluate the safety and tolerability of Peginterferon alpha 2 b in healthy human subjects. Subjects will undergo a screening procedure at least once within 21 days prior to dosing. Upon entering into the study, the subjects will be housed in the clinical facility of the trial site from at least 10 hours before dosing till 48 hours post-dose blood sampling.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Male subjects aged between 18 and 45 years (including both).
- •weight within ±15% of the ideal height-weight chart of Life Insurance Corporation of India for non-medical cases.
- •Ability to communicate effectively with study personnel.
- •Willingness to adhere to the protocol requirements.
- •Able to give consent for participation in the trial.
- •Normal health as determined by personal medical history, clinical examination, and laboratoryexaminations data during screening(within the clinically acceptable range ).
排除标准
- •History of hypersensitivity to Peginterferon alpha 2 b or any other related drug.
- •Preexisting increase in Interferon response marker (baseline serum neopterin concentration).
- •Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal.
- •Renal insufficiency (serum creatinine > 1.5 mg/dL).
- •History of depression necessitating hospitalisation, two or more recurrent episodes of depression, or suicide attempt.
- •History of epilepsy.
- •History or presence of blood dyscrasias (eg., thrombocytopenia, neutropenia).
- •History or presence of thyroid disorders.
- •History or presence of pulmonary disorders (eg., dyspnoea, pneumonia)
- •History or presence of autoimmune disorders (eg., thyroiditis, rheumatoid arthritis).
- •History or presence of arrhythmia or any other cardiovascular disease.
- •History or presence of eye disorders (e.g., retinal haemorrhage).
- •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).
- •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).
- •History or presence of significant alcoholism or drug abuse within the past one-year.
- •History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products.
- •Difficulty with donating blood.
- •Pulse less than 60/minute or more than 100/minute.
- •Any ECG abnormalities.
- •Major illness during 3 months before the screening period
- •Subjects who have participated in drug research studies within past 3 months.
- •Subjects who have donated one unit (350ml) of blood in the past 3 months.25.
结局指标
主要结局
Peak serum concentration (Cmax), time to reach peak serumconcentration (Tmax), area under serum concentration vs. time curve till the last time point (AUC0-t), area under serum concentration vs. time curve extrapolated to the infinity (AUC0-infinity), the residual area in percentage (AUC_% Extrap), serum elimination half-life (t1/2), elimination rate constant
时间窗: For Pharmacodynamic analysis: A total of 10 blood samples will be collected. The venous blood samples will be collected at predose and at 6.00, 12.00, 24.00, 48.00, 72.00, 96.00, 120.00, 144.00 and 168.00 hours following drug administration.For Pharmacokinetic Analysis: A total of 13 blood samples will be collected. The venous blood samples will be withdrawn at predose and at 4.00, 6.00, 8.00, 10.00 12.00, 15.00, 24.00, 48.00, 72.00, 120.00, 168.00, and 192.00 hours following drug administration.
次要结局
未报告次要终点