Comparison of Budesonide and Formoterol Absorption From Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Charcoal; Formoterol Fumarate

Criteria

Inclusion Criteria:

1. Healthy males and females aged 18-60 years.

2. Normal weight, at least 50 kg.

Exclusion criteria

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.

2. Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.

3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.

4. Known hypersensitivity to the active substance(s) or the excipient of the drug.

5. Pregnant or lactating females.