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Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics

Information source: Orion Corporation, Orion Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: budesonide and formoterol 200/6 microg (Drug); budesonide and formoterol 200/6 microg (Drug); budesonide and formoterol 200/6 microg (Drug); budesonide and formoterol 200/6 microg (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Orion Corporation, Orion Pharma

Official(s) and/or principal investigator(s):
Ulla Sairanen, MSc, Study Director, Affiliation: Orion Corporation, Orion Pharma

Summary

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

Clinical Details

Official title: Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males or females aged 18-60 years with documented diagnosis of asthma

- Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the

predicted value

- The asthma should be stable on the same regular treatment for at least 4 weeks before

screening. Exclusion Criteria:

- Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the

screening

- Respiratory infection within 4 weeks preceding the screening

- Any condition requiring regular concomitant treatment or likely to need concomitant

treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide

- Any disorder or 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

Locations and Contacts

Medicines Evaluation Unit, Manchester M23 9QZ, United Kingdom
Additional Information

Starting date: September 2009
Last updated: February 12, 2010

Page last updated: August 23, 2015

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