Healthy
Conditions
Brief summary
This study aims to demonstrate the bioequivalence between the formulation of Budesonide 1mg/2mL nebuliser suspension (IMP 08P1707F0) relaive to the reference product Pulmicort(r) 1.0mg/2mL suspension.
Interventions
DRUGbudesonide
Budesonide 1 mg/2mL nebuliser suspension
OTHERActivated Charcoal
suspension of 10g activated charcoal slurried in 70mL of water
Sponsors
Analytical Clinical Concepts (ACC GmbH)
Unither Pharmaceuticals, France
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single dose, randomized, open-label, two-formations, three treatments, four-period, four-sequence, cross-over, at one study site.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy, Caucasian, male and female (16 male, 8 female) subjects 18 - 55 years of age * Body mass index within the range of ≥ 18.5 and ≤ 30.0 kg/m2 * Female subjects of childbearing potential1) agree to undergo pregnancy tests and to use at least an acceptable effective birth control method during the study and until 90 days after study end * Negative Covid-19 test result * Findings within the range of clinical acceptability in medical history (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study) * Findings within the range of clinical acceptability in physical examination (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study) * Laboratory values within the normal range (or the clinical investigator considers the deviation to be irrelevant for the purpose of the study) * Normal Electrocardiograms (ECG) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study * Normal vital signs (normal blood pressure and heart rate measured under stabilised conditions at screening visit after at least 5 minutes of rest in sitting position: systolic blood pressure 100 - 140 mmHg, diastolic blood pressure 60 - 90 mmHg and heart rate 50 - 100 beats per minute; normal body temperature (Forehead, 35.5 °C - 37.0 °C)) or abnormalities which the clinical investigator does not consider a disqualification for participation in the study (...)
Exclusion criteria
* History of hypersensitivity to the study drug or any related drugs or to any of the excipients * History or presence of any clinically significant cardiovascular, pulmonary, hepatobiliary, renal, haematological, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, malignant disease or eye disorders as glaucoma or a family history of glaucoma * Clinically significant abnormal laboratory values * Clinically significant ECG findings * Clinically significant vital signs (...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours | The maximum concentration in plasma among observed concentrations at pre-specified time points |
| AUC 0-t of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours | The area under the curve of plasma concentration versus time curve from time O to the last measured concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC O-30 min of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42 and 0.50 hours | — |
| t max of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours | — |
| t 1/2 of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours | — |
| AUC 0-∞ of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours | — |
| λz of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours | λz Elimination rate constant (calculated by log linear regression of concentrations observed during the terminal phase of elimination) |
| Incidence of treatment-related adverse events | up to 24 hours | Occurence and severity of adverse events (serious and non serious adverse events) |
| AUC O-15 min of budesonide for the differents arms | predose, 0.05, .010, 0.17 and 0.25 hours | — |
| AUC t-∞ of budesonide for the differents arms | predose, 0.05, .010, 0.17, 0.25, 0.33, 0.42, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00 and 24.00 hours | — |
Countries
Turkey (Türkiye)
Outcome results
None listed