Pharmacodynamics and pharmacokinetics of two formulations containing a synergic mixture of interferons in healthy volunteers.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点目标入组 16 人开始时间: 2011年5月24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: Other

•1) Body mass index between 19 and 29 Kg/m2. 2) Hematological parameters (hemogram, globular sedimentation rate, coagulogram) within normal limits. 3) Biochemical parameters (glucose, cholesterol, creatinine, urea, uric acid, alkaline phospatase, transaminases, bilirubin, others) within normal limits. 4) Urine analysis (density, pH, glucose, bilis, leukocytes, erythrocytes) within normal limits. 5) No reactive serology and negative to HIV, hepatitis B and C virus infections markers in serum. 6) No consumption of drugs in the previous 15 days. 7) No symptoms or signs of any disease at the physical examination. 8) Written, informed consent to participate.

•1) No fulfillment of any inclusion criteria. 2) History of chronic diseases. 3) Suffer any acute illness in the previous 30 days. 4) Smoking habit. 5) History of allergic reactions or hypersensibility to drugs (including antipyretics and interferons) and any ingredient of both studied formulations (considering investigator criteria) 6) Alcoholism (more than a quarter of rum bottle, one wine bottle or three beers, more than two times per week), or addiction to drugs in the previous year. 7) Surgical interventions in the previous 6 months. 8) Blood donation in the previous 2 months. 9) Treatment with any type of interferon at any moment previous inclusion. 10) To have been included in another clinical trial with therapeutic intervention in the previous year before inclusion.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.