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Systemic exposure bio equivalence study between 2 formulations of orally inhaled fluticasone propionate and salmeterol xinafoate - Trial PACTR201506001172164

Access comprehensive clinical trial information for PACTR201506001172164 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.

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.

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PACTR201506001172164
Not Applicable
Completed
other
Trial Details
Pan Africa Clinical Trials Registry • PACTR201506001172164
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Systemic exposure bio equivalence study between 2 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 50/25 mcg per actuation, administered from a pressurized metered dose inhaler (pMDI), 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 with the already marketed product, through the measurement of blood level profiles and determination of pharmacokinetic systemic exposure (Cmax and AUC). 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

PACTR201506001172164

Non-Device Trial