EUCTR2015-003278-34-IT进行中（未招募）1 期
A RANDOMIZED, CROSS-OVER, BIOEQUIVALENCE STUDY OF EFAVIRENZ TABLETS 600 mg OF MYLAN SpA AND SUSTIVA® (EFAVIRENZ) TABLETS 600 mg OF BRISTOL MYERS SQUIBB AT STEADY STATE IN PATIENTS WITH HIV-1 - EFAVIRENZ
IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 40 人开始时间: 2021年6月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Able to understand and willing to sign written informed consent form, obtained before any screening procedure;
- •2.Male or female, aged 18 years or older;
- •3.Body Mass Index> 18.5 Kg/m2 to < 30.0 Kg/m2;
- •4.Patient currently receiving an antiretroviral regimen containing Efavirenz by a period of 6 months before the screening visit;
- •5.Documented plasma HIV-1 RNA levels <37 copies/mL (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is >37 copies/mL, Abbott RT-PCR kit HIV-1) for 6 months preceding the screening visit;
- •6.Willing and able to comply with protocol requirements;
- •7.A female subject is eligible to enter the study if it is confirmed that she is:
- •a.Not pregnant or breastfeeding;
- •b.With a negative serum pregnancy test at screening visit;
- •c.Of non-childbearing potential (i.e., women who have had a hysterectomy, have had both ovaries removed or medically documented ovarian failure, or are postmenopausal women> 54 years of age with cessation (for >12 months) of previously occurring menses and appropriate post-menopausal FSH elevation, or
- •d.Of childbearing potential and agrees to utilize highly effective protocol-specified contraceptive method or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last study drug dose;
- •e.utilizes hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Evidence of gastro-intestinal diseases influencing drug absorption;
- •2.Evidence of decompensated cirrhosis (e.g., ascites, encephalopathy, etc.);
- •3.Evidence of allergy or intolerance to the study drugs or their components or drugs of their class, or a history of drug or other allergy
- •4.Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance;
- •5.Participation in any clinical trial within last three months;
- •6.Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication;
- •7.Presence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening;
- •8.Hepatic transaminases (AST and ALT) >3 × upper limit of normal (ULN)
- •9.Not adequate renal function in terms of estimated glomerular filtration rate <50 mL/min according to the Cockcroft-Gault formula: Male: (140 – age in years) x (wt in kg) = CLcr (mL/min)72 x (serum creatinine in mg/dL); Female: (140 – age in years) x (wt in kg) x 0.8 = CLcr (mL/min)72 x (serum creatinine in mg/dL).
- •10.Any change to the antiretroviral combination in the month preceding the first study drug administration
研究者
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