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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.
Eligible participant will receive 3 single-dose treatments; 2 doses of BDA MDI HFA and 1 dose of BDA MDI HFO.
The study will comprise of:
Each participant has to be involved in the study for up to 48 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A (BDA MDI HFO) | Drug | Randomized participants will receive Treatment A (BDA MDI HFO) on Day 1 under fasted condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Day 1, Day 2 (pre-dose and post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration-time curve from time 0 to infinity (AUCinf) | The AUCinf after administration of budesonide and albuterol will be evaluated. | Day 1, Day 2 (pre-dose and post-dose) |
| Time to reach maximum observed concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States |
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| Label | URL |
|---|---|
| D6933C00001\_CSR synopsis\_Redacted | View source |
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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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
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This is a Partial-replicate, 3-period Cross-over study.
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Since this is a double-blind study, so the investigator, all clinical staff involved in the clinical study, the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding.
| Treatment B (BDA MDI HFA) | Drug | Randomized participants will receive Treatment B (BDA MDI HFA) on Day 1 under fasted condition. |
|
The Tmax after administration of budesonide and albuterol will be evaluated.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From Screening (≤ 28 days to Day -2) until Follow-up phone call (within 3 to 7 days post final dose) |