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Bioequivalence Study to Assess Systemic Exposure of FP and SAL FDC From Different DPIs

Asthma Clinical Trial

Official title:
A Bioequivalence Study to Assess the Systemic Exposure of Fluticasone Propionate and Salmeterol Administered as a Fixed Dose Combination From Different Dry Powder Inhalers in Healthy Subjects

Clinical Trial Summary

This is a crossover study to assess the systemic pharmacokinetics of fluticasone propionate (FP) and salmeterol (SAL). Study medication will be administered as fixed dose combinations (250 µg FP and 50 µg SAL) from the Advair® Diskus®, Seretide™ Accuhaler™ and CRC749 inhalers.

Clinical Trial Description

Study drug will be administered through the inhaled route to healthy subjects in single doses (three inhalations, i.e. total dose 750 µg FP and 150 µg SAL). Each subject will receive the following treatments in a random order: A. MGR001 B. Seretide™ Accuhaler™ C. Advair® Diskus® There will be a wash out of 3 7 days between treatment periods. Pharmacokinetics will be assessed by the measurement of plasma concentrations of FP and SAL over the 48 hours following dosing. Adverse Events will be collected throughout the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02215122
Study type Interventional
Source Viatris Inc.
Contact
Status Completed
Phase Phase 1
Start date October 2013
Completion date November 2013
View Details
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