An Open Study to Investigate the Effect of Two Times Oral 100 mg Ritonavir Capsules on Pharmacokinetics of Single Doses of BILR 355 BS (Dose Steps: 5 and 12.5 mg) Dissolved in 5 mL PEG 400 After Oral Administration in Healthy Male Volunteers, and a Double Blind, Placebo Controlled Study for Doses From 25 mg to 100 mg BILR 355 BS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Maximum observed concentration of the analyte in plasma (Cmax)
研究概览
简要总结
Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a single dose of BILR 355 BS dissolved in PEG 400
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
- Double
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All participants in the study should be healthy males
- •Age range from 21 to 50 years
- •Body mass index (BMI) be within 18.5 to 29.9 kg/m2
- •In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •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 at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- •Any laboratory value outside the clinically accepted reference range
- •Excessive physical activities within the last week before the trial or during the trial
- •Following exclusion criteria are of special interest for this study:
- •Erythema, exanthema and comparable skin alterations
研究组 & 干预措施
D3
干预措施: Ritonavir (Drug)
D1
干预措施: BILR 355 BS, D1 (Drug)
D1
干预措施: Ritonavir (Drug)
D2
干预措施: BILR 355 BS, D2 (Drug)
D2
干预措施: Ritonavir (Drug)
D3
干预措施: BILR 355 BS, D3 (Drug)
D4
干预措施: BILR 355 BS, D4 (Drug)
D4
干预措施: Ritonavir (Drug)
D5
干预措施: BILR 355 BS, D5 (Drug)
D5
干预措施: Ritonavir (Drug)
D6
干预措施: BILR 355 BS, D6 (Drug)
D6
干预措施: Ritonavir (Drug)
D7
干预措施: BILR 355 BS, D7 (Drug)
D7
干预措施: Ritonavir (Drug)
D8
干预措施: BILR 355 BS, D8 (Drug)
D8
干预措施: Ritonavir (Drug)
D10
干预措施: BILR 355 BS, D10 (Drug)
D10
干预措施: high-fat breakfast (Other)
D10
干预措施: Ritonavir (Drug)
Placebo
for D3 - D10
干预措施: Placebo (Drug)
Placebo
for D3 - D10
干预措施: Ritonavir (Drug)
结局指标
主要结局
Maximum observed concentration of the analyte in plasma (Cmax)
时间窗: up to 120 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
时间窗: up to 120 hours after drug administration
Time to reach Cmax (tmax)
时间窗: up to 120 hours after drug administration
Total mean residence time (MRTtot)
时间窗: up to 120 hours after drug administration
Urinary excretion (Ae)
时间窗: up to 72 hours after drug administration
Area under the concentration-time curve (AUC)
时间窗: up to 120 hours after drug administration
Total clearance of the analyte in plasma (CL/F)
时间窗: up to 120 hours after drug administration
Renal clearance (CLR)
时间窗: up to 72 hours after drug administration
Apparent volume of distribution (Vz/F)
时间窗: up to 120 hours after drug administration
次要结局
- Number of subjects with adverse events(up to 26 days)