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PACTR201608001741317

Systemic exposure study between three formulations of orally inhaled fluticasone propionate and salmeterol xinafoate

An exploratory, single-centre, single-dose, open-label, randomised, three-way crossover study to investigate the pharmacokinetics of three orally inhaled formulations containing fluticasone propionate and salmeterol (as xinafoate) 50/25 ¿g per actuation administered from a pressurised metered dose inhaler, in at least 24 healthy male and female subjects
Circassia Limited·Not Applicable·Pan Africa Clinical Trials Registry·drugCompleted
Study focus
Disease/Condition
Respiratory; Other
Intervention type
drug
Sponsor & location
Primary sponsor
Circassia Limited
Location
South Africa
Timeline & enrollment
Phase
Not Applicable
Start date
Sep 22, 2016
End date
Oct 14, 2016
Summary

The fluticasone propionate/salmeterol (as xinafoate) fixed dose combination to be administered in this study is indicated for the treatment of asthma. The two classes of medication used in this combination product have different effects on clinical and physiological indicators.The primary objective is to investigate the single-dose PK profiles for two test products (fluticasone propionate (as xinafoate) 50/25 µg per actuation via pDMI and the reference product, Seretide® Evohaler® 50/25 µg per actuation via pMDI, under fasting conditions in healthy male and female subjects.

ICD-10 classifications
Other specified respiratory disordersOther respiratory disordersOther diseases of the respiratory systemOther postprocedural respiratory disordersOther respiratory conditions due to chemicals, gases, fumes and vapours
Data source
Registry
Pan Africa Clinical Trials Registry
Trial ID
PACTR201608001741317
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for PACTR201608001741317 through Pure Global AI's free database. This Not Applicable trial is sponsored by Circassia Limited and is currently Completed. The study focuses on Respiratory; Other.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Pan Africa Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.