NCT02256826已完成1 期
Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
研究概览
简要总结
To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR 355 BS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females who meet the inclusion/exclusion criteria; females must not be pregnant or nursing, and agree to use a double-barrier method of birth control (condoms or diaphragm plus spermicide) throughout the trial (alone or in addition to other methods of birth control such as oral contraceptives)
- •Age ≥18 and <60 years
- •BMI ≥18.5 and BMI ≤29.9 kg/m2
- •Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations
排除标准
- •Current (symptomatic within the last 30 days) and medically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of gastrointestinal tract (except appendectomy)
- •Currently active (symptomatic within the last 30 days) diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of relevant orthostatic hypotension, fainting spells or blackouts
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (>24 hours) within one month prior to administration of study drug or during the trial (review with clinical monitor if questionable)
- •Use of drugs within 10 days prior to administration or during the trial, which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation (review with clinical monitor if questionable)
- •Participation in another trial with an investigational drug within one month prior to administration or during the trial
- •Current smoker
- •Alcohol (more than 60 g/day) or drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse)
- •Recent blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- •Excessive physical activities (within 1 week prior to study drug administration or during the trial)
- •Any laboratory value outside the normal reference range that is of clinical relevance at screening, according to the judgment of the investigator
- •Inability to comply with dietary regimen required by the protocol
- •Chronic or relevant acute infections
- •Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive)
- •HIV-1 infected as defined by a positive HIV ELISA test
研究组 & 干预措施
Group A
Experimental
干预措施: BILR 355 BS (Drug)
Group A
Experimental
干预措施: Ritonavir (RTV) (Drug)
Group A
Experimental
干预措施: Kaletra® (Drug)
Group B
Experimental
干预措施: BILR 355 BS (Drug)
Group B
Experimental
干预措施: Ritonavir (RTV) (Drug)
结局指标
主要结局
Maximum measured concentration of the analyte in plasma at steady state over a dosing interval τ (Cmax,ss)
时间窗: Up to 96 h after the last drug administration of BILR 355
Area under the concentration-time curve of the analyte in plasma over one dosing interval (12 hours) at steady state (AUC0-12h,ss)
时间窗: Up to 12 h after the last drug administration of BILR 355
次要结局
- Apparent clearance of the analyte in plasma following extravascular administration at steady state (CL/F,ss)(Up to 96 h after the last drug administration of BILR 355)
- Apparent volume of distribution during the terminal phase λz at steady state following an extravascular dose (Vz/F,ss)(Up to 96 h after the last drug administration of BILR 355)
- Measured concentration of the analyte in plasma 12 hours post last dose at steady state (Cp12h,ss)(Up to 12 h after the last drug administration of BILR 355)
- Area under the plasma concentration time curve (0-12 hours) (AUC0-12h) for RTV(Up to 12 h after RTV administration)
- Number of participants with Adverse Events(Up to day 35 after first drug administration)
- Number of participants with clinically significant changes in vital signs(Up to day 35 after first drug administration)
- Terminal half-life of the analyte in plasma at steady state (t1/2,ss)(Up to 96 h after the last drug administration of BILR 355)
- Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss) for RTV(Up to 96 h after the last drug administration of BILR 355)
- Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax,ss)(Up to 96 h after the last drug administration of BILR 355)
- Number of participants with abnormal changes in clinical laboratory parameters(Up to day 35 after first drug administration)
- Number of participants with abnormal findings in physical examination(Up to day 35 after first drug administration)
研究者
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