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Systemic exposure study between three formulations of orally inhaled fluticasone propionate and salmeterol xinafoate - Trial PACTR201608001741317

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.

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PACTR201608001741317
Not Applicable
Completed
drug
Trial Details
Pan Africa Clinical Trials Registry • PACTR201608001741317
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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

Study Focus

Respiratory; Other

drug

Sponsor & Location

Circassia Limited

South Africa

Timeline & Enrollment

Not Applicable

Sep 22, 2016

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 disorders
Other respiratory disorders
Other diseases of the respiratory system
Other postprocedural respiratory disorders
Other respiratory conditions due to chemicals, gases, fumes and vapours

Data Source

Pan Africa Clinical Trials Registry

PACTR201608001741317

Non-Device Trial