This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers.
This is a randomized, open label, single-center, single-dose, four-period crossover clinical study to assess the pharmacokinetic profile and safety of a budesonide inhalation solution (AQ001S) compared to a budesonide inhalation suspension (comparator) in healthy volunteers. Three (3) different AQ001S concentrations (i.e. 0.125 mg/2 mL, 0.250 mg/2mL and 0.500 mg/2 mL) will be compared to budesonide inhalation suspension 1.0 mg/2 ml. Twenty (20) male and female healthy volunteers, from 18 to 60 years old, must complete the study. The study drug will be administered by nebulization. The primary PK objective is to characterize the pharmacokinetic (PK) profile of AQ001S inhalation solution. The primary safety objective is to assess the safety of AQ001S inhalation solution.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Single-dose of budesonide solution administered by nebulization.
MC Comac Medical Ltd.
Sofia, Bulgaria
Assessment of pharmacokinetics (Cmax) of budesonide through analysis of blood samples
Blood samples will be collected from each subject using an indwelling intravenous catheter. In total 17 blood samples for PK assessments over 24 hours will be collected.
Time frame: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Assessment of pharmacokinetics (Tmax) of budesonide through analysis of blood samples
Blood samples will be collected from each subject using an indwelling intravenous catheter. In total 17 blood samples for PK assessments over 24 hours will be collected.
Time frame: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Assessment of pharmacokinetics (AUC) of budesonide through analysis of blood samples
Blood samples will be collected from each subject using an indwelling intravenous catheter. In total 17 blood samples for PK assessments over 24 hours will be collected.
Time frame: Day 1 (predose) and at 2', 5', 10', 15', 20', 30', 45', 60', 90', 120', 180', 240', 360', 10h, 18h and 24h postdose
Assessment of the safety through to incidence of Adverse Events of AQ001S inhalation solution
Incidence of treatment-related adverse events (AE), including acute bronchospasm
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to vital signs (blood pressure: systolic and diastolic blood pressure) of AQ001S inhalation solution
Vital signs assessment through blood pressure (systolic and diastolic blood pressure)
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to vital signs (pulse rate) of AQ001S inhalation solution
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vital signs assessment through pulse rate
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to vital signs (respiratory rate) of AQ001S inhalation solution
Vital signs assessment through respiratory rate
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (PR interval duration)
ECG assessment through to PR interval duration
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (heart rhythm) of AQ001S inhalation solution
ECG assessment through to heart rhythm
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (QRS interval duration) of AQ001S inhalation solution
ECG assessment through to QRS interval duration
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (Corrected QT interval (QTc)) of AQ001S inhalation solution
ECG assessment through to Corrected QT interval
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to ECG (QT interval duration) of AQ001S inhalation solution
ECG assessment through to QT interval duration
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the general tolerability through to physical examination
General tolerability through the rate of patients with observed abnormalities in the following organic systems: general appearance, head and neck (incl. oropharyngeal examination), skin, respiratory system, cardiovascular system, abdomen, urogenital system, nervous system, ear, eyes and nose, musculoskeletal system
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the local tolerability through to increased bronchial irritability of AQ001S inhalation solution
Incidence of Increased bronchial irritability
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the local tolerability through to paradoxical bronchospasm of AQ001S inhalation solution
Incidence of paradoxical bronchospasm
Time frame: From baseline up to 17 days after first study drug intake
Assessment of the local tolerability through to oropharyngeal examination ((e.g. vocal cord myopathy, fungal infection) of AQ001S inhalation solution
Incidence of oropharyngeal examination ((e.g. vocal cord myopathy, fungal infection)
Time frame: From baseline up to 17 days after first study drug intake