DRKS00017760已完成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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
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 history of hereditary fructose intolerance
- •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 (i.e., outside PR interval of 113 to 212 milliseconds, QRS interval of 69 to 109 milliseconds, frontal plane QRS axis of -40 degrees to 91 degrees and/or QTc-Fridericia of 359 to 445 milliseconds)
- •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 only if a drug with systemic action was not taken within five elimination half-lives [as described in the SmPC of the respective drug] prior to intake of the study medication, 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 only if a drug with systemic action was not taken within five elimination half-lives [as described in the SmPC of the respective drug] prior to intake of the study medication)
- •subjects who received chronic drug treatment (> 3 days) within eight weeks before the first trial day (exceptions possible upon decision of principal investigator only if a drug with systemic action was not taken within five elimination half-lives [as described in the SmPC of the respective drug] prior to intake of the study medication)
- •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 showing typical symptoms for infection SARS-CoV-2 within 48 hours prior to hospitalization at ward. These typical symptoms are fever, cough, diarrhoea, sore throat, loss of taste and smell
- •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 24 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 lif
研究者
相似试验
已完成
1 期
A randomised, two-period two-stage cross-over study on the relative bioavailability of two different formulations of single doses of rifampicin (phase I/IV, open-label) in healthy volunteers (fasted state)healthy volunteersDRKS00014602InfectoPharm Arzneimittel und Consilium GmbH (Ansprechpartner: Dr. Bertil Wachall)24
进行中（未招募）
不适用
Study to compare two different oral preparations of noscapine in order to proof equality of both drugshealthy subjectsEUCTR2014-003151-62-DEInfectopharm Arzneimittel und Consilium GmbH
进行中（未招募）
1 期
Study to compare two different oral preparations of noscapine in order to proof equality of both drugsHealthy controlsEUCTR2019-002012-12-DEInfectoPharm Arzneimittel und Consilium GmbH96
进行中（未招募）
1 期
A Phase 2 study comparing the pharmacokinetics and assessing safety and tolerability of peripheral and central intravenous administration of melflufen in patients with relapsed and refractory multiple myeloma.Patients with relapsed and refractory multiple myeloma.MedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851EUCTR2019-004127-21-BGOncopeptides AB25
进行中（未招募）
1 期
A Phase 2 study comparing the pharmacokinetics and assessing safety and tolerability of peripheral and central intravenous administration of melflufen in patients with relapsed and refractory multiple myeloma.EUCTR2019-004127-21-CZOncopeptides AB20