EUCTR2019-002012-12-DE进行中（未招募）1 期
A randomised, two-period two-stage cross-over study on the relative bioavailability of two different liquid formulations of single noscapine doses (phase I/IV, open-label) in healthy volunteers (fasted state)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Male/female
- •Age: between 18 and 64 years old (inclusive)
- •Body Mass Index: 18.5 - 30 kg/m²
- •considered healthy on the basis of extensive pre-study screening
- •willing and capable to confirm written consent to enrolment after ample information has been provided
- •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 96
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •subjects with suspicion of hypersensitivity to noscapine or any of the excipients listed in the respective medical product information
- •subjects with any relevant clinical abnormality as based on extensive medical history, physical examination, vital signs (i.e., PR outside the interval of 50-90 beats per minute and BP outside the 90-140 mmHg (systolic) and/or 60-90 mmHg (diastolic) intervals) and 12-lead ECG
- •subjects with a history of a major surgical abdominal intervention or of peritonitis within the last year
- •subjects with psychoses (current or history)
- •subjects with any clinically relevant laboratory abnormality
- •subjects receiving any medication within 1 week prior to study start or during the study (exceptions possible upon decision of Principal Investigator, e.g. paracetamol single dose for acute pain or topical aciclovir for herpes labialis)
- •subjects who have taken a drug with a long half-life (> 24 hours) within four weeks before the first trial day (exceptions possible upon decision of principal investigator)
- •subjects who received chronic drug treatment (> 3 days) within eight weeks before the first trial day (exceptions possible upon decision of principal investigator)
- •subjects who participated in a trial with novel investigational medications within the last 8 weeks before the start of the present study
- •subjects who participated in a trial with a registered compound within the last 4 weeks before the start of the present study
- •subjects who donated blood or plasma within the last 4 weeks before the start of the present study
- •subjects who smoke, i.e. subjects who smoked one or more cigarettes during the last six months
- •subjects who are known or suspected to be (social) drug dependent, incl. those drinking usually more than 28 g alcohol per day (male) respectively 14 g alcohol per day (female)
- •subjects with a history of alcohol or recreational drug addiction
- •subjects with a history of any severe disease that might interfere with the study objectives (e.g. psychiatric disease, epilepsy)
- •subjects who are not willing or able to abstain from alcohol, methylxanthine-containing beverages and foods (coffee, tea, cocoa products), and grapefruit, orange, and apple flesh/juice for 72:00 h before first study drug administration until 48 hours after last study drug administration
- •subjects who adhere to a special diet (e.g. vegetarians) or lifestyle (incl. working at night and extreme physical activities such as competitive sports and weight lifting) that might interfere with the investigation
- •subjects planning elective hospital treatment within one month after last intake of trial medication
- •subjects who are known or suspected not to comply with the study directives and/or known or suspected not to be reliable or trustworthy
- •subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the foreseeable risks and discomfort to which they will be exposed.
- •subjects with anticipated problems of successfully placing an indwelling venous catheter at a forearm
- •female subjects only: positive results in pregnancy test
- •female subjects only: lactating women
- •female subjects (within fertile age) only: subjects who do not use or do not agree to use appropriate contraceptive methods during the study as defined in Note for Guidance on Non-Clinical Safety Studies f
研究者
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