Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BDA MDI 160 · 1 trial · 1 indication
To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler
To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler
To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler
| Arm | Type | Description |
|---|---|---|
| A/B (BDA MDI/Pulmicort) | EXPERIMENTAL | For each participant, the BDA MDI/Pulmicort Flexhaler DPI will be administered as a single dose (2 inhalations) on Day 1 of the respective treatment period per the assigned treatment sequence. The IMP will be administered in the morning, at approximately the same time of day throughout the study (±30 minutes). |
| B/A (Pulmicort/ BDA MDI) | EXPERIMENTAL | For each participant, the Pulmicort Flexhaler DPI / BDA MDI will be administered as a single dose (2 inhalations) on Day 1 of the respective treatment period per the assigned treatment sequence. The IMP should be administered in the morning, at approximately the same time of day throughout the study (±30 minutes). |
| Name | Type | Description |
|---|---|---|
| BDA MDI 160/180 mcg | DRUG | Budesonide/albuterol sulfate pressurized inhalation suspension, single dose given as 2 inhalations of 80/90 mcg. |
| Pulmicort Flexhaler 180 mcg | DRUG | Pulmicort Flexhaler aerosol, power, single-dose given as 2 inhalations of 90 mcg. |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and female participants aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at the Scre...
BDA MDI 160 is an investigational small molecule developed by AstraZeneca PLC (ticker AZN). It is a metered dose inhaler formulation studied for relative bioavailability, meaning researchers measured how much of the delivered drug reaches the bloodstream compared with another inhaler product. The program is in Phase 1 clinical development and its broader therapeutic indications have not been disclosed.
BDA MDI 160 is also referred to as BDA MDI 160/180 mcg. The two names describe the same AstraZeneca inhaler asset, with the alternate form including the microgram strength designations. Readers searching either term are looking at the same Phase 1 program and the same clinical study record.
BDA MDI 160 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 study evaluating the asset. No other development partners are identified for this program.
BDA MDI 160 is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. The program has one completed Phase 1 trial, and no active trials are currently listed for this asset.
BDA MDI 160 has been studied in one completed Phase 1 trial, NCT03934333, titled a study to compare the pharmacokinetics of budesonide delivered by PT027 compared with Pulmicort Flexhaler (ELBRUS). The trial enrolled 11 participants in the United States, used a controlled design, and included healthy volunteers aged 18 years and older.
The completed Phase 1 trial NCT03934333 measured relative bioavailability, comparing the pharmacokinetics of budesonide delivered by PT027 with Pulmicort Flexhaler. It was a controlled study with 11 enrolled participants, conducted in the United States in healthy volunteers aged 18 years and older. The trial is listed as completed.