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 being studied for relative bioavailability, which measures how much of a drug is absorbed into the bloodstream. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 1 clinical development.
BDA MDI 160 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical development for relative bioavailability.
BDA MDI 160 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed, with no active trials currently ongoing.
BDA MDI 160 has been studied in one completed Phase 1 clinical trial, identified as NCT03934333. The trial, titled 'A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)', enrolled 11 participants in the United States.
BDA MDI 160 is associated with the trial name PT027, which is used in the clinical trial NCT03934333 to describe the budesonide formulation being studied. The trial compares the pharmacokinetics of budesonide delivered by PT027 with Pulmicort Flexhaler.