IRCT201111027978N1已完成4 期
In local healthy human volunteers after single subcutaneous dose of 20 kDa peginteferon ?-2a (from Unipeg?) evaluation of safety and pharmacokinetics of the drug
Getz Pharma (Pvt) Limited0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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 45 years（—）
- 性别
- Male
入选标准
- •Healthy human volunteers, BMI: 18-26 Kg/m2, non-smoker, non-alcoholic, with normal lab reports for CBC, LFT, HBsAg, Anti HCV, HIV antibody
- •Any active allergic disease or a history of significant allergic disease.
- •Presence of renal, hepatic or gastrointestinal disease known to interfere with the drug absorption, distribution, metabolism or elimination with in last year.
- •Subject demonstrates protocol non-compliance (e.g. uncooperative attitude, & inability to finish study).
- •Participation in another study within last 2 months of 1st drug administration.
- •If donated blood within last 2 months preceding the study.
- •Age below 18 years and above 45yr.
- •Smoking within last 3 months prior to the drug administration and 6 hours after drug administration.
- •Ingestion of OTC drug (except Paracetamol) within last 14 days of 1st drug administration.
- •Participants with insufficient organ and/or bone marrow dysfunction.
- •Ingestion of investigational drug within 1 year prior to 1st drug administration.
- •Participants with low blood counts and hematology results outside the normal range. (ANC) absolute neutrophile count should be > 1500/mm3 and platelete count should be grater then 50,000/ mm3 .
- •Participants with an uncontrolled medical condition (i.e., hypertension, cardiac arrhythmias, CHF) that places the patient at risk by participating in the study.
- •Participants with any physical/mental disability
- •Subjects with known HIV, hepatitis B or hepatitis C infection, or autoimmune diseases.
- •History of major organ transplantation, new onset diabetes, unstable thyroid function.
- •Concurrent therapy with immunosuppressive drugs or cytotoxic agents.
- •Alcohol or drug abuse within the past year.
- •Known hypersensitivity to investigational drug
- •Participants with uncontrolled brain metastases or central nervous system disease.
- •Strenuous physical activity performed within 48 hours before drug administration and during study.
- •Positive drug of abuse test and alcohol test.
- •Intake of gutka, pan and any other thing containing nicotine 48 hours before and during study.
- •Volunteer with thyroid dysfunction.
排除标准
- 未提供
研究者
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