drugset / Trial / NCT02254174
Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to a free dose combination of the marketed products of tiotropium and salmeterol (Spiriva® and Serevent® Diskus®). Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to tiotropium and salmeterol administered as individual mono substances from the marketed products. Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol in a PE (Polyethylene) capsule administered via the HandiHaler® 2
Timeline
- Start
- 2006-03
- Primary completion
- 2006-07
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Salmeterol | Other / unclassified | 25 ug | Inhaled |
| Subject | Salmeterol | Other / unclassified | 50 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 7.5 ug | Inhaled |
| Subject | Tiotropium | Other / unclassified | 18 ug | Inhaled |
| Subject | salmeterol xinafoate | Unknown | 50 ug | Inhaled |
Indications
No indication recorded.