Table 3.
Parameter | IN Administration (Test) | Comparison (E as Reference) | Ratio (Test/Reference) of Adjusted Meansa | 90% CI for Ratio |
---|---|---|---|---|
Cmax/Dose | INND 2-mg × 1 IN (Trt A) | A vs E | 37.2 | 32.1-43.0 |
INND 2-mg × 2 IN (Trt B) | B vs E | 29.6 | 25.5-34.2 | |
2-mg FDANxSpray IN (Trt C) | C vs E | 93.2 | 80.6-108 | |
4-mg FDANxSpray IN (Trt D) | D vs E | 76.4 | 66.0-88.4 | |
AUC /Dose | INND 2-mg IN (Trt A) | A vs E | 23.3 | 21.2-25.7 |
INND 2-mg × 2 IN (Trt B) | B vs E | 19.6 | 17.7-21.8 | |
2-mg FDANxSpray IN (Trt C) | C vs E | 61.7 | 56.0-68.0 | |
4-mg FDANxSpray IN (Trt D) | D vs E | 54.6 | 49.7-60.1 |
AUC/Dose, AUC per mg naloxone administered; Cmax/Dose, Cmax per mg naloxone administered; CI, confidence interval; INND, improvised nasal naloxone device; IN, Intranasal; Trt, Treatment.
Geometric least-squares mean ratio between treatments, expressed as a percentage of Reference (Treatment E, 2 mg IM using IM 2-mg autoinjector device)