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Pharmacokinetic Pilot Study on Budesonide/Formoterol Easyhalers and Symbicort Turbuhaler; an Open, Randomised, Single Centre, Single Dose Study With Crossover Design in Healthy Subjects (Reco-Pilot)
Due to the complexity of orally inhaled products (combination of a formulation and a device)and the topical nature of drug delivery to the lung for efficacy in vitro-in vivo correlation(IVIVC) for inhaled dosage forms is not generally known. The rationale of this pilot study is to gain in vivo data of the Budesonide/formoterol EH product variants under development and compare pulmonary deposition (administration with charcoal) of different product variants of Budesonide/formoterol EH with Symbicort TH.
Details
| Lead sponsor | Orion Corporation, Orion Pharma |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 20 |
| Start date | 2010-08 |
| Completion | 2010-11 |
Conditions
- Asthma
Interventions
- Budesonide/formoterol 320/9 μg and 400/12 μg inhalers
Primary outcomes
- The maximum observed concentration of concentration-time curve. — 24 hours
Countries
Finland