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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00625196 | Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects | PHASE1 | COMPLETED | 16 | — | — | Feb 27, 2008 | May 6, 2008 | Aug 21, 2017 | 1 | Australia |
| Arm | Type | Description |
|---|---|---|
| Subjects receiving fluticasone foroate/ vilanterol | EXPERIMENTAL | Eligible subjects will receive single dose of fluticasone foroate/ vilanterol combination treatment 800 micrograms/ 50 micrograms administered using a novel powder inhaler. There will be a washout period of 7 to 10 days between treatments. |
| Subjects receiving fluticasone foroate | ACTIVE_COMPARATOR | Eligible subjects will receive single dose of fluticasone foroate 800 micrograms administered using a novel powder inhaler. |
| Subjects receiving vilanterol | ACTIVE_COMPARATOR | Eligible subjects will receive single dose of vilanterol 50 micrograms administered using a novel powder inhaler. |
| Subjects receiving placebo | PLACEBO_COMPARATOR | Eligible subjects will receive single dose of placebo administered using a novel powder inhaler. |
| Name | Type | Description |
|---|---|---|
| Fluticasone foroate/ vilanterol | DRUG | Fluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler. |
| Fluticasone foroate | DRUG | Fluticasone foroate 800 micrograms will be available as dry powder inhaler. |
| Vilanterol | DRUG | Vilanterol will be available as dry powder inhaler. |
| Placebo | DRUG | Placebo will be supplied as dry powder inhaler. |
Inclusion criteria: * Healthy male adults aged between 20 and 60 years inclusive * Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory p...