Status:
COMPLETED
Bioequivalence of IMP 08P1707F0 Relative to Pulmicort® (1.0 Mg/2 Ml Suspension)
Lead Sponsor:
Unither Pharmaceuticals, France
Collaborating Sponsors:
Analytical Clinical Concepts (ACC GmbH)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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 (...)
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06595121
Start Date
August 13 2024
End Date
September 16 2024
Last Update
November 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Farmagen IKU Merkezi
Gaziantep, Turkey (Türkiye), 27000