Trials / Completed
CompletedNCT00868426
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler
Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler, Symbicort Turbuhaler; an Open, Single Center, Single Dose Study With 3-way Crossover Design in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Orion Corporation, Orion Pharma · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of budesonide and formoterol after administration from 2 different batches of Symbicort TH is compared with each other.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Budesonide/Formoterol Batch 1 | Single, inhaled dose |
| DRUG | Budesonide/Formoterol Batch 2 | Single, inhaled dose |
| DRUG | Budesonide/Formoterol Batch 1 and charcoal | Single, inhaled dose |
Timeline
- Start date
- 2009-04-01
- Primary completion
- 2009-05-01
- Completion
- 2009-05-01
- First posted
- 2009-03-25
- Last updated
- 2009-08-13
Locations
1 site across 1 country: Finland
Source: ClinicalTrials.gov record NCT00868426. Inclusion in this directory is not an endorsement.