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Systemic exposure bioequivalence study between two formulations of orally inhaled fluticasone propionate and salmeterol xinafoate. - Trial PACTR201508001221356

Access comprehensive clinical trial information for PACTR201508001221356 through Pure Global AI's free database. This Not Applicable trial is sponsored by Prosonix Limited and is currently Completed. The study focuses on Respiratory; Other.

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PACTR201508001221356
Not Applicable
Completed
other
Trial Details
Pan Africa Clinical Trials Registry • PACTR201508001221356
Pure Global
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Systemic exposure bioequivalence study between two formulations of orally inhaled fluticasone propionate and salmeterol xinafoate.
A single center, single dose, open label, randomized, two period crossover study to determine the bioequivalence of two formulations containing fluticasone propionate and salmeterol xinafoate 250/25 mcg per actuation, administered from a pressurized metered dose inhaler (pMDI) via a valved holding chamber, in at least 60 healthy male and female subjects without charcoal under fasting conditions

Study Focus

Respiratory; Other

other

Sponsor & Location

Prosonix Limited

South Africa

Timeline & Enrollment

Not Applicable

Jan 01, 1900

Jan 01, 1900

Summary

To determine the bioequivalence of a new formulation of orally inhaled fluticasone propionate and salmeterol xinafoate, when administered through a valved holding chamber, with the already marketed product, through the measurement of blood level profiles and determination of pharmacokinetic systemic exposure (Cmax and AUC), following charcoal block. The eventual objective is to obtain a marketing authorisation for the new formulation generic product.

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

PACTR201508001221356

Non-Device Trial