Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1... | NCT06595121

NCT06595121

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Analytical Clinical Concepts (ACC GmbH)	UNKNOWN

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMP 08P1707F0 without charcoal	Experimental	Budesonide 1mg/2mL nebuliser suspension (08P1707F0) without charcoal	Drug: budesonide
IMP 08P1707F0 with charcoal	Experimental	Budesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal	Drug: budesonide Other: Activated Charcoal
Pulmicort 1.0mg/2mL Suspension	Active Comparator	Pulmicort 1.0mg/2mL Suspension (First administration)	Drug: budesonide
Pulmicort 1.0mg/ML suspension (second administration)	Active Comparator	Pulmicort 1.0mg/ML suspension (second administration)	Drug: budesonide

Name	Type	Description	Arm Group Labels	Other Names
budesonide	Drug	Budesonide 1 mg/2mL nebuliser suspension	IMP 08P1707F0 with charcoal IMP 08P1707F0 without charcoal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax of budesonide for the differents arms	The maximum concentration in plasma among observed concentrations at pre-specified time points	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-t of budesonide for the differents arms	The area under the curve of plasma concentration versus time curve from time O to the last measured concentration	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

Secondary Outcomes

Measure	Description	Time Frame
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
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

Eligibility Module

Eligibility Criteria

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 (...)

Type	Date	Date Unknown
Release	Apr 28, 2026
Reset	May 20, 2026

ID	Term
D019819	Budesonide
D002606	Charcoal