Fluticasone propionate (FP), a topically active corticosteroid shows little or no systemic activity after oral administration is indicated for the prophylactic management of asthma of all severities. The aim of these studies was to determine the bioequivalence of test and reference formulations of fluticasone propionate HFA pMDI 250 mcg per actuation with and without a spacer device. Study-1 was a single dose, randomized, 4-period, 2-sequence, laboratory-blinded, crossover replicate design conducted in 32 healthy volunteers under fasting conditions without Volumatic spacer. Study-2 was a single dose, randomized, 2-period, 2-sequence, laboratory-blinded, crossover design conducted in 28 healthy volunteers under fasting conditions with Volumatic spacer. Both the studies had a washout period of 14 days. Blood samples were collected up to 36 hours post-dose for pharmacokinetic profiling. Safety evaluations included monitoring adverse events and vital signs as well as clinical laboratory assessments. Plasma concentrations of fluticasone propionate were determined using a validated LC-MS/MS method. The 90% CI of the difference between the test and reference for fluticasone propionate was 97.46-112.34 and 98.55-113.06 for Cmax, and AUC0-t respectively in study-1. The 90% CI of the difference between the test and reference for fluticasone propionate was 88.13-104.88, and 96.21-111.22 for Cmax, and AUC0-t respectively in study-2. Since the 90% CI of fluticasone propionate for Cmax and AUC0-t were within the 80–125% interval in both the studies, it was concluded that test and reference formulations of fluticasone propionate HFA pMDI 250 mcg per actuation are bioequivalent in their rate and extent of absorption with and without a spacer device.
