Table 2.

Average bioequivalence results obtained in pivotal study

	C max Point estimate (%) (90% CI)	AUC Point estimate (%) (90% CI)
Combined analysis (n = 36)	111.84 (100.97–123.89)	105.17 (98.89–111.85)
Males (n = 17)	109.98 (96.51–125.34)	102.09 (95.51–109.12)
Females (n = 19)	111.14 (93.92–131.50)	106.94 (95.99–119.15)
Combined analysis with ANOVA including sex	111.82 (100.76–124.08)	105.04 (98.69–111.79)
P‐value of sex*formulation	0.95	0.55
Ratio between point estimates of females and males	101.05%	104.75%
Point estimate of the sex*formulation interaction and its 90% CI	100.79 (81.61–124.48)	104.63 (92.20–118.73)