Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate … (NCT06139991) | Clinical Trial Compass
CompletedPhase 1
Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.
United States66 participantsStarted 2023-11-16
Plain-language summary
This study will investigate the Pharmacokinetic (PK) and safety of Budesonide and albuterol (BDA) metered dose inhaler (MDI) HFO and BDA MDI HFA in healthy male and female participants.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Healthy male and female participants (of non-childbearing potential) aged 18 to 60 years, inclusive, with suitable veins for cannulation or repeated venipuncture.
* Female participants must have a negative pregnancy test at screening and on admission and must not be lactating.
* Participants with Body mass index between 18 and 30 kg/m\^2, inclusive, and weighing between 50 kg and no more than 120 kg inclusive.
* Participants must have a Forced expiratory volume (FEV)1 ≥ 80% of the predicted normal value and an FEV1/FVC\> 70% regarding age, height, and ethnicity at the screening visit.
* Participants must demonstrate proper inhalation technique and is able to use an MDI properly after training.
Exclusion Criteria:
* History or presence of gastrointestinal, hepatic or renal disease, or any other clinically significant disease or disorder.
* History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
* Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
* Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results at the screening.
* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, or Human immunodeficiency virus (HIV).
* Any clinically …
What they're measuring
1
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)