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Pharmacokinetic Pilot Study on Budesonide/Formoterol Device-metered Dry Powder Inhaler

2014-08-27 03:23:24 | BioPortfolio

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.

Study Design

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

Conditions

Healthy

Intervention

Budesonide/Formoterol Batch 1, Budesonide/Formoterol Batch 2, Budesonide/Formoterol Batch 1 and charcoal

Location

Orion Pharma Phase I Unit
Espoo
Finland
02101

Status

Completed

Source

Orion Corporation, Orion Pharma

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:23:24-0400

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

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.

Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations

The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP pro...

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The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults

Quality of Life Assessment in Greek asthmatIc Patients Treated With the Fixed Dose Combination of Budesonide / Formoterol in Clinical Practice

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PubMed Articles [743 Associated PubMed Articles listed on BioPortfolio]

Controlled Trial of Budesonide-Formoterol as Needed for Mild Asthma.

In double-blind, placebo-controlled trials, budesonide-formoterol used on an as-needed basis resulted in a lower risk of severe exacerbation of asthma than as-needed use of a short-acting β-agonist (...

Low-Dose Budesonide/Formoterol Counteracts Airway Inflammation and Improves Lung Function in COPD.

Beta -adrenergic ligand racemic formoterol exhibits enantioselective disposition in blood and skeletal muscle of humans, and elicits myocellular protein kinase A-signalling at therapeutic inhaled doses.

While studies have demonstrated substantial differences in beta -adrenergic agonist enantiomer pharmacology, enantioselective disposition of long-acting beta -adrenergic ligand racemic (rac)-formotero...

Enantioselective disposition of (R,R)-formoterol, (S,S)-formoterol and their respective glucuronides in urine following single inhaled dosing and application to doping control.

Formoterol is a long-acting beta2-adrenoceptor agonist (LABA) used for treatment of asthma and exercise-induced bronchoconstriction. Formoterol is usually administered as a racemic (rac-) mixture of (...

Budesonide, Aclidinium and Formoterol in combination limit inflammaging processes in bronchial epithelial cells exposed to cigarette smoke.

Inflammation and cellular senescence (also called inflammaging) are involved in the pathogenesis of premature lung aging, a key driver of chronic obstructive pulmonary disease (COPD). Downregulation o...

Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

A pharmaceutical preparation of mometasone furoate and formoterol fumarate that is used as an inhaled dosage form for the treatment of ASTHMA.

A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.

An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

Methods for cultivation of cells, usually on a large-scale, in a closed system for the purpose of producing cells or cellular products to harvest.

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