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Pharmacokinetic Pilot Study on Budesonide/Formoterol

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: Healthy

Intervention: Budesonide (Drug); Formoterol (Drug); Easyhaler (Device); Turbohaler Forte (Device)

Phase: N/A

Status: Completed

Sponsored by: Orion Corporation, Orion Pharma

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

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.

Clinical Details

Official title: Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler: A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Cmax of Budesonide and Formoterol

AUCt of Budesonide and Formoterol

Secondary outcome:

AUCinf of Budesonide and Formoterol

tmax of Budesonide and Formoterol

t1/2 of Budesonide and Formoterol

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Parexel International GmbH, Berlin, Germany
Additional Information

Starting date: October 2011
Last updated: February 2, 2012

Page last updated: August 23, 2015

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