Bioequivalence study of Abacavir tablets (300 mg) in HIV+ patients

Center for Pharmaceutical Research and Development, Havana, Cuba0 个研究点目标入组 30 人开始时间: 2017年9月27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- HIV-positive patients diagnosed with two Western Blot tests positive (at least two HIV envelope proteins) which are covered by the sanatorium system or Ambulatory Care System (SAA).
•2- Written informed consent.
•3- Aged between 18-50 years.
•4- Patients from both sexes.
•5- Patient’s weight: +/- 15% of ideal weight for height.
•6- Not have evidence or history of diseases such as bronchial asthma, peptic or duodenal ulcer, liver failure, kidney failure, severe allergic reactions, atopic dermatitis, cardiovascular disorders, diabetes mellitus.
•7- No opportunistic infections at the onset of the study.
•8- Satisfactory physical examination.
•9- Do not be ingesting medication at the time of the study or in the 15 days before the start of it.
•10- Present vital signs values within the following reference ranges. Systolic blood pressure between 90 and 130 mm Hg and diastolic blood pressure between 60 and 80 mm Hg, heart rate between 60 to 100 beats per minute, respiratory rate between 12 to 20 breaths per minute.
•11- Not having consumed alcohol, drinks containing xanthines (tea, coffee, and cola) and carbonated beverages three days before the start of each period and during it.
•12- Patients of childbearing potential must use effective contraception up to three months after completion of treatment.

•1- Pregnancy and / or breastfeeding.
•2- Previous antiretroviral treatment or current criteria for antiretroviral therapy treatment.
•3- Post-menopausal women (age 45 or older with at least two years of amenorrhea) or documented history of hysterectomy and / or oophorectomy double sex.
•4- Known history of allergies or drug, or to any component of the formulations studied (at the discretion of the investigator) hypersensitivity.
•5- Refer viral disease in the last 7 days.
•6- To be ingesting some medication 15 days (or for 5 half-lives) before the first dose of product research or nonprescribed or free drugs (OTC drugs) or herbal medicines / dietary supplements in a period seven days before the first dose of research products until the end of the study.
•7- Serum creatinin values higher than 1.5 times the upper limit of the reference range.
•8- Values of AST and ALT higher than 2 times the upper limit of the reference range.
•9- Positive for hepatitis B and C and serology results.
•10- History of alcoholism in the past 6 months (not less consumption ¼ bottle of rum or one (1) bottle of wine or three (3) beers in a higher frequency of twice a week.
•11- Patients with a history of drug consumption dependence or drug abuse.
•12- To be undergone major surgery within 6 months prior to baseline.

发起方

Center for Pharmaceutical Research and Development, Havana, Cuba