NCT06723756CompletedPhase 1
A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults
A Phase I, Randomized, Double-blind, Single-dose, Partial Replicate, 3-way Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA in Healthy Adult Participants
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 4 Dec 2024
- Start date
- 23 Jan 2025
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Asthma
- NCT number
- NCT06723756
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 105
- From 23 Jan 2025 to the primary completion date, 1 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of any clinically significant disease that put the participant at risk of participation.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, history of narrow angle glaucoma not adequately treated, or bladder neck obstruction/urinary retention.
- Unresectable cancer that has not been in complete remission for at least 5 years.
- History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
- Known or suspected history of alcohol or drug abuse as judged by the Investigator.
Lab values
- Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
Other
- Any clinically significant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis results, or vital signs at Screening.
- Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at Screening.
- Current smokers or those who have smoked or used nicotine products (including e cigarettes).
- Excessive intake of caffeine-containing drinks or food.
Who the study is looking for
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
- Participants must have a forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value (based on age, height, ethnicity and gender at birth) and an FEV1/forced vital capacity (FEV1/FVC) \> 70% at the Screening Visit. FEV1/FVC can be reported as ratio ie, 0.7 or a percentage ie, 70%.
- Participants must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.