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)
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00017760
- Lead Sponsor
- InfectoPharm Arzneimittel und Consilium GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
• 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
•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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main pharmacokinetic parameters of noscapine: AUC0-24, Cmax
- Secondary Outcome Measures
Name Time Method Additional pharmacokinetic parameters of noscapine (AUC0-8, residual area, tmax, ?z, t½,?z) as well as safety and tolerability parameters