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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03155204 | Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product | EARLY_PHASE1 | COMPLETED | 46 | — | — | Apr 25, 2017 | Mar 19, 2018 | Dec 2, 2024 | 1 | United Kingdom |
noncompartmental analysis
| Arm | Type | Description |
|---|---|---|
| Test Product 1 | EXPERIMENTAL | tiotropium pMDI 2 inhalations |
| Test Product 2 | EXPERIMENTAL | tiotropium pMDI 2 inhalations |
| Test Product 3 | EXPERIMENTAL | tiotropium pMDI 2 inhalations |
| Test Product 4 | EXPERIMENTAL | tiotropium pMDI 2 inhalations |
| Commercial Product | ACTIVE_COMPARATOR | tiotropium Respimat 2 inhalations |
| Name | Type | Description |
|---|---|---|
| tiotropium pMDI | DRUG | inhalation |
Inclusion Criteria: * Healthy Volunteer * Willing and able to give informed consent * Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * Subjects must agree to use an adequate method of contraception ...