Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03934333 | A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS) | PHASE1 | COMPLETED | 11 | — | — | May 16, 2019 | Sep 10, 2019 | Oct 1, 2019 | 1 | United States |
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...