Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension) (BUNIPILOT)

Unither Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: budesonide; Other: Activated Charcoal

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06595121

UP-CLI-2022-001

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 (...)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

IMP 08P1707F0 without charcoal

Experimental group

Description:

Budesonide 1mg/2mL nebuliser suspension (08P1707F0) without charcoal

Treatment:

Drug: budesonide

Drug: budesonide

IMP 08P1707F0 with charcoal

Experimental group

Description:

Budesonide 1mg/2mL nebuliser suspension (08P1707F0) with charcoal

Treatment:

Other: Activated Charcoal

Drug: budesonide

Drug: budesonide

Pulmicort 1.0mg/2mL Suspension

Active Comparator group

Description:

Pulmicort 1.0mg/2mL Suspension (First administration)

Treatment:

Drug: budesonide

Drug: budesonide

Pulmicort 1.0mg/ML suspension (second administration)

Active Comparator group

Description:

Pulmicort 1.0mg/ML suspension (second administration)

Treatment:

Drug: budesonide

Drug: budesonide