Pharmacokinetics and pharmacodynamics comparison of two pegylated interferon alpha-2 formulations in healthy volunteers.

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 16 人开始时间: 2008年10月7日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Active. Assignment: Crossover. Purpose: Treatment

•1. Absence of antecedents from chronic diseases. 2. Absence of antecedents from acute diseases in the last 30 days. 3. Absence of symptoms and signs with the physical examination and laboratory test. 4. Seronegatives for HIV, hepatitis B and hepatitis C tests. 5. Voluntariness of the individual through the signing of the informed consent. 6.18-35 years of age. 7. Quetelet Index (19-29), (weight in kg, height in square meter). 8. Male.

•1. Personal pathological antecedents from chronic diseases. 2. Individuals who have undergone treatment with some type of interferon in the last 30 days. 3. To refer some acute viral disease in the last 30 days. 4. To be under medication that can alter immunity. 5. Antecedents of allergy, idiosyncracy or hypersensitivity to a drug. 6. Surgery during the 6 previous months to the study initiation. 7. Blood donation three months before the study initiation. 8. Antecedents of alcoholism.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)