Open-Label, Randomized, Parallel-group, Comparative Study of Pharmacokinetics and Bioequivalence of VM-1500FDC (Viriom Ltd, Russia) and Elpida® (Viriom Ltd, Russia) and Truvada® (Gilead Sciences Ireland UC, UK) When сo-administrated Once Daily Fasting in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Plasma concentration of VM1500A
研究概览
简要总结
Open-label, randomized, parallel-group, comparative study of pharmacokinetics and bioequivalence of VM-1500FDC (elsulfavirine/emtricitabine/tenofovir fixed-dose combination) and Elpida® with Truvada® (emtricitabine/tenofovir) co-administered by healthy male subjects. The study will also assess safety profile of study drugs.
详细描述
The study assesses PK and bioequivalence of the developed new drug VM-1500FDC - a fixed combination of three active substances: elsulfavirine (NNRTI), emtricitabine (NRTI) and tenofovir (NRTI) to Elpida® and Truvada® co-administered. The combination is intended for once daily administration (1 tablet) for the treatment of HIV-1 infection in adult patients. Thus, the purpose of this combination is to simplify the dosage regimen and improve patient compliance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking male subjects between the ages of 20 and 40 years (inclusive);
- •Verified diagnosis of "healthy" according to standard clinical, laboratory and instrumental examination methods;
- •Body weight from 60 to 95 kg and Body Mass Index from 19.0 to 27.0 kg/m;
- •A negative result in tests for alcohol and drugs;
- •The subject's consent to use adequate contraception methods during the study and 3 month after end of study: condom with spermicide (foam, gel, cream, suppositories);
- •Signed the Participant Explanation Sheet and the Informed Consent Form.
排除标准
- •Chronic diseases of cardiovascular, bronchopulmonary, neuroendocrine, musculoskeletal system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood;
- •Variables of standard laboratory and instrumental parameters are beyond the normal limits Variables of standard laboratory and instrumental parameters are beyond the normal limits (taking into account the acceptable limits of laboratory parameters);
- •Surgical interventions on the gastrointestinal tract in medical history (except appendectomy);
- •Systolic pressure less than 90 mm Mercury or above 130 mm Mercury, diastolic pressure less than 60 mm Mercury or above 85 mm Mercury, heart rate less than 60 BPM or more than 90 BPM at screening;
- •Regular intake of drugs less than 2 weeks prior to screening (including herbal preparations and dietary supplements); intake of drugs that have a pronounced effect on hemodynamics, liver function, etc. (for example, barbiturates, omeprazole, cimetidine, etc.) less than 30 days prior to screening;
- •Presence of antibodies to HIV and hepatitis C virus, presence of hepatitis В surface antigen, a positive syphilis test;
- •An unstable sleep structure (e.g., night work, sleep disorders, insomnia, recent return from another time zone, etc.), extreme physical activity (e.g. weight lifting), a special diet (e.g. vegetarian, vegan);
- •Signs of alcohol (taking more than 10 units of alcohol per week ) or drug addiction; alcohol or drugs consumption within 4 days prior to screening; cigarettes smoking 3 months prior to screening; positive drug and/or alcohol test;
- •Burdened allergic medical history (including drug intolerance and food allergy);
- •Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
- •Hypersensitivity to tenofovir, elsulfavirine or emtricitabine, as well as any other component of the study drugs;
- •Blood/plasma donation (450 ml of blood or plasma and more) less than 2 months prior to screening;
- •Treatment with a study drug in framework of other clinical trials within 30 days prior to screening (including follow-up visits);
- •Acute infectious diseases less than 4 weeks prior to screening;
- •Incapable of reading or writing; no desire to understand and adhere to the study protocol procedures; non-compliance with the drugs intake regimen or execution of procedures, which as the Investigator may think may affect the study results or subject's safety and prevent the subject from further participation in the study; any other associated medical or serious psychological conditions making the subject not eligible to participate in the clinical study, restricting legality of obtaining the informed consent or affecting the subject's ability to take part in the study.
研究组 & 干预措施
VM-1500FDC
VM-1500FDC (tenofovir 300 mg/elsulfavirine 20 mg/emtricitabine 200 mg), once daily fasting
干预措施: VM-1500FDC (Drug)
Elpida® & Truvada®
Elpida®, 20 mg + Truvada® (tenofovir 300 mg / emtricitabine 200 mg), once daily fasting
干预措施: Elpida® (Drug)
Elpida® & Truvada®
Elpida®, 20 mg + Truvada® (tenofovir 300 mg / emtricitabine 200 mg), once daily fasting
干预措施: Truvada® (Drug)
结局指标
主要结局
Plasma concentration of VM1500A
时间窗: 29 days
Plasma concentration of tenofovir
时间窗: 29 days
Plasma concentration of elsulfavirine
时间窗: 29 days
Plasma concentration of emtricitabine
时间窗: 29 days
次要结局
- Frequency and severity of AEs and SAEs(29 days)