NCT02256709已完成1 期
Safety, Tolerability and Pharmacokinetics of BIBP 5371 CL Following Oral Administration to Healthy Male and Female Volunteers (Dose Range: 10 - 350 mg). A Double-blind (Within Treatment Groups), Randomised, Placebo-controlled, Single Rising Dose Study, Including Comparisons of 50 mg vs. 100 mg Tablet and Tablet vs. Drinking Solution, and Investigation of Food Effect
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
- 70
- 主要终点
- Number of patients with changes in electrocardiogram (ECG)
研究概览
简要总结
Safety, tolerability and pharmacokinetics (including comparisons of different formulations and investigation of food effect)
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers
- •Age 21 - 50 years
- •Body mass index (BMI) 18.5 - 29.9 kg/m2
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate, respiratory rate, body temperature and ECG) deviating from normal
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system or psychiatric disorders or neurological disorders
- •History of relevant 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 1 month or less than 10 half-lives of the respective drug before enrolment in the study
- •Use of any drugs which might influence the results of the trial (within 1 week prior to administration or during the trial)
- •Participation in another trial with an investigational drug (within 2 months prior to administration or during the trial)
- •Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 grams/day)
- •Drug abuse
- •Blood donation (≥ 100 mL within 4 weeks prior to administration or during the trial)
- •Excessive physical activities (within the last week before the study)
- •Any laboratory value outside the reference range of clinical relevance
- •In addition, for female subjects:
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception e.g. oral contraceptives, intrauterine device, sterilisation
- •Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condoms) prior to administration of study medication, during the study and at least 1 month after release from the study
- •Inability to maintain this adequate contraception during the whole study period
- •Lactation period
研究组 & 干预措施
BIBP 5371 CL tablet low dose
Experimental
to be compared with same daily dose level from single rising dose arm
干预措施: BIBP 5371 CL tablet low dose (Drug)
BIBP 5371 CL tablet high dose
Experimental
to be compared with same daily dose level from single rising dose arm
干预措施: BIBP 5371 CL tablet high dose (Drug)
single rising dose BIBP 5371 CL
Experimental
干预措施: BIBP 5371 CL tablet (Drug)
Placebo drinking solution
Placebo Comparator
干预措施: Placebo drinking solution (Drug)
BIBP 5371 CL drinking solution
Experimental
干预措施: BIBP 5371 CL solution (Drug)
BIBP 5371 CL tablet high dose with food
Experimental
干预措施: High fat, high caloric breakfast (Other)
BIBP 5371 CL tablet high dose with food
Experimental
干预措施: BIBP 5371 CL tablet high dose (Drug)
BIBP 5371 CL tablet low dose with food
Experimental
干预措施: High fat, high caloric breakfast (Other)
BIBP 5371 CL tablet low dose with food
Experimental
干预措施: BIBP 5371 CL tablet low dose (Drug)
Placebo tablet
Placebo Comparator
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Number of patients with changes in electrocardiogram (ECG)
时间窗: baseline, up to 8 days after drug administration
Number of patients with adverse events
时间窗: baseline, up to 8 days after drug administration
Global tolerability assessment by the investigator on a verbal rating scale
时间窗: up to 8 days after drug administration
Number of patients with changes in vital signs
时间窗: baseline, up to 8 days after drug administration
blood pressure, pulse rate, respiratory rate, body temperature
Number of patients with changes in safety laboratory parameters
时间窗: baseline, up to 8 days after drug administration
次要结局
- λz (terminal rate constant in plasma)(up to 32 hours after drug administration)
- Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(up to 32 hours after drug administration)
- t1/2 (terminal half-life of the analyte in plasma)(up to 32 hours after drug administration)
- MRTpo (mean residence time of the analyte in the body after po administration)(up to 32 hours after drug administration)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(up to 32 hours after drug administration)
- tmax (time from dosing to maximum concentration)(up to 32 hours after drug administration)
- %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation)(up to 32 hours after drug administration)
- fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)(up to 32 hours after drug administration)
- Cmax (maximum concentration of the analyte in plasma)(up to 32 hours after drug administration)
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 32 hours after drug administration)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(up to 32 hours after drug administration)
- CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)(up to 32 hours after drug administration)
研究者
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