Pharmacokinetic Pilot Study on Budesonide/Formoterol

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• Healthy males and females, 18-55 years of age.

• Normal weight at least 50 kg.

Exclusion Criteria:

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

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

• Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study.

• Known hypersensitivity to the active substance(s) or to any of the excipients of the drug.

• Pregnant or lactating females.