NCT00743015已完成1 期
Relative Bioavailability Following Single Oral Administration of 200 mg of BI 44370 During and Between Migraine Attacks in Male and Female Migraine Patients. An Open-label, Fixed-sequence, Two-period Study With Intraindividual Comparison
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Cmax (maximum concentration of BI 44370 BS in plasma)
研究概览
简要总结
The general aim is to evaluate the relative oral bioavailability of BI 44370 TA tablets during and between migraine attacks as well as Safety, Tolerability and Pharmacokinetic
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female migraine patients (age 18 to 65 years) with or without aura, diagnosed according to IHS criteria.
- •Established migraine diagnosis for >= 1 year.
- •Age at migraine onset <= 50 years.
- •Well documented (for >= 3 months) retrospective history of migraine with headache of moderate to severe intensity and with an attack duration of at least 6 hours and migraine frequency of 2-8 times / month
- •Other forms of headache are permitted if they on average occur on not more than 10 days / month and if the patient is able to differentiate migraine headache from other forms of headache.
- •Patient has provided written informed consent in accordance with ICH-GCP and local legislation.
- •Patient is in general good health based om screening assessment
排除标准
- •Women of child-bearing potential without an adequate method of contraception
- •Any woman of child-bearing potential not having a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline
- •Breastfeeding women
- •Males not willing to use adequate contraception (condom use plus another form of contraception e.g. spermicide, oral contraceptive taken by female partner, sterilization, IUD [intrauterine device]) during the whole study period from the time of the first intake of study drug until three months after the last intake.
- •History of hemiplegic, ophthalmoplegic, or basilar migraine or cluster headache.
- •History of treatment resistant migraine attacks, defined as a lack of response to a range of commonly used acute anti-migraine compounds.
- •History of , clinical evidence for, or screening/baseline findings suggestive of significant medical disorders (e.g. cardiovascular, peripheral vascular, hepatic, respiratory, haematological, renal, gastrointestinal, immunological, metabolic, hormonal, neurological or psychiatric disorders)
- •Smokers ... (cont.)
结局指标
主要结局
Cmax (maximum concentration of BI 44370 BS in plasma)
时间窗: 48 hours
AUC0-∞ (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 extrapolated to infinity)
时间窗: 48 hours
tmax (time from dosing to maximum measured concentration)
时间窗: 48 hours
AUC0-2 (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to 2 h after drug administration)
时间窗: 48 hours
次要结局
- Changes from baseline in Physical examination(48 hours)
- Changes from baseline in 12-lead electrocardiogram (ECG)(48 hours)
- AUC0-tz (area under the concentration-time curve of BI 44370 BS in plasma over the time interval from 0 to the time of the last quantifiable data point)(48 hours)
- %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)(48 hours)
- AUCt1-t2 (Area under the concentration-time curve of BI 44370 BS in plasma over the time interval t1 to t2)(48 hours)
- λz (terminal rate constant in plasma)(48 hours)
- t1/2 (terminal half-life of BI 44370 BS in plasma)(48 hours)
- MRTp.o. (mean residence time of BI 44370 BS in the body after p.o. administration)(48 hours)
- CL/F (Apparent clearance of BI 44370 BS in plasma after extravascular administration)(48 hours)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(48 hours)
- Ae0-12 (amount of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)(48 hours)
- fe0-12 (fraction of BI 44370 BS eliminated in urine from time point 0 - 12 h after drug administration)(48 hours)
- CLR,0-12 (renal clearance of BI 44370 BS from time point 0 - 12 h after drug administration)(48 hours)
- Changes from baseline in Vital signs: Blood pressure (BP) and pulse rate (PR)(48 hours)
- Assessment of tolerability by investigator(48 hours)
- Occurrence of Adverse events (AEs)(48 hours)
- Number of participants with abnormalities in clinical laboratory parameters(48 hours)
研究者
研究点 (2)
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