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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03302065 | Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference | PHASE1 | COMPLETED | 38 | — | — | May 1, 2016 | Jan 1, 2017 | Dec 2, 2024 | - | — |
| NCT02676297 | Cross-over Study in Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Test and Reference Products | PHASE1 | COMPLETED | 26 | — | — | Jan 1, 2016 | Jul 1, 2016 | Dec 2, 2024 | 1 | United Kingdom |
| NCT02627625 | Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Two Reference Products | PHASE1 | COMPLETED | 31 | — | — | Nov 1, 2015 | Jun 1, 2016 | Dec 2, 2024 | 1 | United Kingdom |
maximum plasma concentration
measured by noncompartmental analysis
noncompartmental analysis
| Arm | Type | Description |
|---|---|---|
| Test Product 1 Tiotropium | EXPERIMENTAL | 4 inhalations |
| Test Product 2 Tiotropium | EXPERIMENTAL | 4 inhalations |
| Test Product 3 Tiotropium | EXPERIMENTAL | 4 inhalations |
| Reference Tiotropium | ACTIVE_COMPARATOR | 2 inhalations |
| Test product A | EXPERIMENTAL | tiotropium |
| Test product B | EXPERIMENTAL | tiotropium |
| reference product | ACTIVE_COMPARATOR | tiotropium |
| test product C | EXPERIMENTAL | tiotropium |
| Commercial product D | ACTIVE_COMPARATOR | tiotropium |
| commercial product E | ACTIVE_COMPARATOR | tiotropium |
| Name | Type | Description |
|---|---|---|
| Tiotropium | DRUG | - |
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 ...