Table 4.
Bioequivalence of fluticasone propionate and salmeterol
| Treatmenta | AUC0–t (pg h/mL) | AUC0–t T/R ratio (90% CI)a | Cmax (pg/mL) | Cmax T/R ratio (90% CI)b |
|---|---|---|---|---|
| Study 1: FP/salmeterol 100/50 µg (n = 64) | ||||
| Fluticasone propionate | ||||
| Test (Wixela) | 600.3 | 1.04 (1.00–1.08) | 103.7 | 0.92 (0.87–0.96) |
| Reference (Advair) | 576.4 | 112.9 | ||
| Salmeterol | ||||
| Test (Wixela) | 696.4 | 1.08 (1.04–1.11) | 347.7 | 1.00 (0.94–1.04) |
| Reference (Advair) | 644.9 | 348.3 | ||
| Study 2: FP/salmeterol 250/50 µg (n = 61) | ||||
| Fluticasone propionate | ||||
| Test (Wixela) | 1251 | 1.07 (1.02–1.13) | 164.2 | 1.01 (0.95–1.07) |
| Reference (Advair) | 1164 | 162.7 | ||
| Salmeterol | ||||
| Test (Wixela) | 641.2 | 1.03 (0.99–1.07) | 296.2 | 0.93 (0.87–1.00) |
| Reference (Advair) | 623.3 | 317.4 | ||
| Study 3: FP/salmeterol 500/50 µg (n = 65) | ||||
| Fluticasone propionate | ||||
| Test (Wixela) | 2689 | 0.97 (0.92–1.00) | 252.8 | 0.90 (0.86–0.93) |
| Reference (Advair) | 2783 | 281.8 | ||
| Salmeterol | ||||
| Test (Wixela) | 672.3 | 1.00 (0.96–1.04) | 334.9 | 0.86 (0.81–0.91) |
| Reference (Advair) | 670.8 | 388.6 | ||
Data presented as natural-log-transformed geometric mean (based on least squares mean)
AUC0–t area under the concentration–time curve from time 0 to the last measurable concentration, CI confidence interval, Cmax maximum plasma concentration, FP fluticasone propionate, R reference product (Advair® Diskus®), S salmeterol, T test product (Wixela® Inhub®)
aThree inhalations were administered in each study, resulting in total FP/S doses of 300/150 µg (study 1), 750/150 µg (study 2), and 1500/150 µg (study 3)
bT and R were bioequivalent if the 90% CIs of the T to R geometric mean ratio were > 0.80 and < 1.25