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PACTR201508001221356

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
Prosonix Limited·Not Applicable·Pan Africa Clinical Trials Registry·otherCompleted
Study focus
Disease/Condition
Respiratory; Other
Intervention type
other
Sponsor & location
Primary sponsor
Prosonix Limited
Location
South Africa
Timeline & enrollment
Phase
Not Applicable
Start date
Jan 01, 1900
End date
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 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
PACTR201508001221356
Type
Non-Device Trial
About this record

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.

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.