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An Open-label, Single-dose, 2-period Cross Over Study in Healthy Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg After Inhalation Via the M3 Turbuhaler Compared With the M2 Turbuhaler
Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 34 |
| Start date | 2014-08 |
| Completion | 2014-11 |
Conditions
- Healthy Volunteers
Interventions
- terbutaline sulphate delivered dose
- terbutaline sulphate metered dose
Primary outcomes
- Area Under the Plasma Concentration-time Curve From Zero to the Time of Last Measurable Concentration [AUC(0-t)] — Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
These will be taken at each treatment period - Maximum Observed Plasma Concentration (Cmax) — Samples will be taken at predose, and at 5, 10, 20, 40, 80, 100 minutes and at 2, 4, 6, 9, 12, 18, 24, 30, and 36 hours postdose
These will be taken at each treatment period
Countries
United Kingdom