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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02934607 | A Study to Assess How Much Drug Reaches the Blood When Given From Symbicort pMDI With Spacer Compared to That of Symbicort pMDI Without Spacer in Healthy Volunteers | PHASE1 | COMPLETED | 50 | — | — | Nov 4, 2016 | Mar 27, 2017 | Aug 20, 2018 | 1 | United Kingdom |
To assess Cmax of Symbicort pMDI administered through a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered through a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess Cmax of Symbicort pMDI administered through a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered through a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
To assess Cmax of Symbicort pMDI administered without a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered without a spacer device without charcoal under fasted condition (total systemic exposure). The analysis was done on pharmacokinetic analysis set.
To assess Cmax of Symbicort pMDI administered without a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
To assess AUC0-t of Symbicort pMDI administered without a spacer device with charcoal under fasted condition (lung exposure). The analysis was done on pharmacokinetic analysis set.
| Arm | Type | Description |
|---|---|---|
| Treatment A | ACTIVE_COMPARATOR | 2 x 160/4.5 µg Symbicort pMDI administered with no spacer device; no activated charcoal (systemic exposure). |
| Treatment B | EXPERIMENTAL | 2 x 160/4.5 µg Symbicort pMDI administered through AeroChamber Plus Flow-Vu spacer device; no activated charcoal (systemic exposure). |
| Treatment C | ACTIVE_COMPARATOR | 160/4.5 µg Symbicort pMDI administered with no spacer device; with activated charcoal (lung exposure). |
| Treatment D | EXPERIMENTAL | 160/4.5 µg Symbicort pMDI administered through AeroChamber Plus Flow-Vu spacer device; with activated charcoal (lung exposure). |
| Name | Type | Description |
|---|---|---|
| Symbicort pMDI with spacer device | DRUG | Relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with a spacer device (test) |
| Symbicort pMDI without spacer device | DRUG | Relative bioavailability of budesonide and formoterol delivered via Symbicort pMDI without a spacer device (reference) |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects aged 18 years (inclusive) and older, with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy ...