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A Single-Dose, Randomized, Open-Label, Crossover, Pivotal, Comparative Bioavailability Study of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in Healthy Volunteers Without Charcoal Block
The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers without charcoal block.
Details
| Lead sponsor | Intech Biopharm Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 45 |
| Start date | 2014-06 |
| Completion | 2014-08 |
Conditions
- Asthma
- Chronic Obstructive Pulmonary Disease (COPD)
Interventions
- Fluticasone propionate
- Salmeterol (as xinafoate)
Primary outcomes
- Area Under Curve (AUC) — Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing
- Maximum plasma concentration (Cmax) — Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing
Countries
Taiwan