Study to assess the pharmacokinetic bioequivalence of budesonide and albuterol with an alternate propellant compared to current propellant.

Study identifier:D6933C00001

ClinicalTrials.gov identifier:NCT06139991

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

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.

Medical condition

Heathy participants

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Treatment A (BDA MDI HFO), Treatment B (BDA MDI HFA)

Sex

All

Estimated Enrollment

Study type

Interventional

Age

18 Years - 60 Years

Date

Study Start Date: 16 Nov 2023

Estimated Primary Completion Date: 13 May 2024

Estimated Study Completion Date: 13 May 2024

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Other

Verification:

Verified 01 Mar 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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 important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
-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.

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Arms	Assigned Interventions
Experimental: Treatment sequence ABB 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.	Drug: Treatment A (BDA MDI HFO) Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition. Drug: Treatment B (BDA MDI HFA) Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition.
Experimental: Treatment sequence BBA 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.	Drug: Treatment A (BDA MDI HFO) Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition. Drug: Treatment B (BDA MDI HFA) Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition.
Experimental: Treatment sequence BAB 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.	Drug: Treatment A (BDA MDI HFO) Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition. Drug: Treatment B (BDA MDI HFA) Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition.

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]