Heathy ParticipantsPhase 1NCT06139991
Study to Assess the Pharmacokinetic Bioequivalence of Budesonide and Albuterol With an Alternate Propellant Compared to Current Propellant.
A Phase 1 study testing Treatment A (BDA MDI HFO) and Treatment B (BDA MDI HFA) in people with Heathy Participants, run by AstraZeneca at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathy Participants
- What is being tested?
- Treatment A (BDA MDI HFO) and Treatment B (BDA MDI HFA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 4 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
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- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
- Known or suspected history of alcohol or drug abuse.
- Positive screen for drugs of abuse, alcohol, or cotinine at screening.
- History or presence of severe allergy/hypersensitivity.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of the study drug.
- Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, mega dose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of study drug.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
- Excessive intake of caffeine-containing drinks or food.
- Vulnerable participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Single-dose, Partial Replicate, 3-period Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide and Albuterol Delivered by BDA MDI Hydrofluoroolefin (HFO) Compared With BDA MDI (Hydrofluoroalkene) HFA.
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.
Read the detailed description
Eligible participant will receive 3 single-dose treatments; 2 doses of BDA MDI HFA and 1 dose of BDA MDI HFO.
- Treatment A: 2 inhalations, single dose of BDA MDI HFO 80/90 μg (test formulation)
- Treatment B: 2 inhalations, single dose of BDA MDI HFA 80/90 μg (reference formulation) Participants will be randomly assigned to receive any 1 of the 3 treatment sequences of ABB, BBA or BAB.
The study will comprise of:
- A screening period of maximum 28 days.
- Three Treatment periods will be up to approximately 22 days (including Follow-up).
- A final follow-up calls within 3-7 days after the last dose of study intervention.
Each participant has to be involved in the study for up to 48 days.
- Conditions
- Heathy Participants
- Being tested
- Treatment A (BDA MDI HFO), Treatment B (BDA MDI HFA)
- Keywords
- Albuterol, Budesonide, Combination product, Hydrofluoralkene propellant, Hydrofluoroolefin propellant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A (BDA MDI HFO)Drug
Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition.
Treatment B (BDA MDI HFA)Drug
Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence ABB | Experimental | Participants will receive Treatment A, followed by Treatment B, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration. Receives: Drug: Treatment A (BDA MDI HFO); Drug: Treatment B (BDA MDI HFA) |
| Treatment sequence BBA | Experimental | Participants will receive Treatment B, followed by Treatment B, followed by Treatment A, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration. Receives: Drug: Treatment A (BDA MDI HFO); Drug: Treatment B (BDA MDI HFA) |
| Treatment sequence BAB | Experimental | Participants will receive Treatment B, followed by Treatment A, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration. Receives: Drug: Treatment A (BDA MDI HFO); Drug: Treatment B (BDA MDI HFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The AUClast of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Maximum plasma drug concentration (Cmax)
The Cmax of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Secondary outcomes (10)
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The AUCinf after administration of budesonide and albuterol will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Time to reach maximum observed concentration (Tmax)
The Tmax after administration of budesonide and albuterol will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Terminal elimination half-life (T1/2λz)
The T1/2λz after administration of budesonide and albuterol will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
The MRT after administration of budesonide and albuterol will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Apparent total body clearance (CL/F)
The CL/F after administration of budesonide and albuterol will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Apparent volume of distribution during the terminal phase (Vz/F)
The Vz/F after administration of budesonide and albuterol will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Ratio Maximum plasma drug concentration (Cmax)
The ratio of Treatment A (test formulation) and Treatment B (reference formulation) Cmax values will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Ratio Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The ratio of Treatment A (test formulation) and Treatment B (reference formulation) AUCinf values will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Ratio Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The ratio of Treatment A (test formulation) and Treatment B (reference formulation) AUClast values will be evaluated.
Measured: Day 1, Day 2 (pre-dose and post-dose)
Number of participants with Adverse Events
The safety and tolerability of single doses of BDA MDI HFO and BDA MDI HFA will be evaluated.
Measured: From Screening (≤ 28 days to Day -2) until Follow-up phone call (within 3 to 7 days post final dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start16 Nov 2023
- Primary completion4 May 2024
- Study completion4 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a Partial-replicate, 3-period Cross-over study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139991
- Sponsor's protocol ID
- D6933C00001
- Status last verified
- May 2026
- First submitted
- 15 Nov 2023
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Single-dose, Partial Replicate, 3-period Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide and Albuterol Delivered by BDA MDI Hydrofluoroolefin (HFO) Compared With BDA MDI (Hydrofluoroalkene) HFA.
- ClinicalTrials.gov ID
- NCT06139991
- Acronym / sponsor ID
- D6933C00001
- Conditions
- Heathy Participants
- Keywords
- Albuterol, Budesonide, Combination product, Hydrofluoralkene propellant, Hydrofluoroolefin propellant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 4 May 2024 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participant will receive 3 single-dose treatments; 2 doses of BDA MDI HFA and 1 dose of BDA MDI HFO.
- Treatment A: 2 inhalations, single dose of BDA MDI HFO 80/90 μg (test formulation)
- Treatment B: 2 inhalations, single dose of BDA MDI HFA 80/90 μg (reference formulation) Participants will be randomly assigned to receive any 1 of the 3 treatment sequences of ABB, BBA or BAB.
The study will comprise of:
- A screening period of maximum 28 days.
- Three Treatment periods will be up to approximately 22 days (including Follow-up).
- A final follow-up calls within 3-7 days after the last dose of study intervention.
Each participant has to be involved in the study for up to 48 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- This is a Partial-replicate, 3-period Cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence ABB | Experimental | Drug: Treatment A (BDA MDI HFO), Drug: Treatment B (BDA MDI HFA)Participants will receive Treatment A, followed by Treatment B, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration. |
| Treatment sequence BBA | Experimental | Drug: Treatment A (BDA MDI HFO), Drug: Treatment B (BDA MDI HFA)Participants will receive Treatment B, followed by Treatment B, followed by Treatment A, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration. |
| Treatment sequence BAB | Experimental | Drug: Treatment A (BDA MDI HFO), Drug: Treatment B (BDA MDI HFA)Participants will receive Treatment B, followed by Treatment A, followed by Treatment B, all treatments as a single dose, with a washout period of minimum 3 days, but no longer than 7 days, between each study dose administration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment A (BDA MDI HFO)Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition. | Drug | Treatment sequence ABB, Treatment sequence BAB, Treatment sequence BBA |
| Treatment B (BDA MDI HFA)Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition. | Drug | Treatment sequence ABB, Treatment sequence BAB, Treatment sequence BBA |
Primary outcome
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
The AUClast of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.
Maximum plasma drug concentration (Cmax)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
The Cmax of budesonide and albuterol will be evaluated to assess the bioequivalence of the total systemic exposure of budesonide and albuterol administered.
10 secondary outcomes
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Time to reach maximum observed concentration (Tmax)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Terminal elimination half-life (T1/2λz)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Apparent total body clearance (CL/F)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Ratio Maximum plasma drug concentration (Cmax)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Ratio Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Ratio Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1, Day 2 (pre-dose and post-dose)
Number of participants with Adverse Events
Time frame: From Screening (≤ 28 days to Day -2) until Follow-up phone call (within 3 to 7 days post final dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- D6933C00001\_CSR synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A (BDA MDI HFO) and Treatment B (BDA MDI HFA) in people with Heathy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast) (time frame: Day 1, Day 2 (pre-dose and post-dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.