Table 4.

Bioequivalence analysis of C_max, AUC_0–t, and AUC_0–∞ of trofinetide following administration in the morning fasted (treatment A [reference]), morning fed (treatment B [test]), and evening fasted (treatment C [test]) states: whole blood pharmacokinetic analysis set

PK parameter	N test	N reference	GMR (%) (test/reference)	90% CI (lower–upper)	Number of subjects falling below, within, or above bioequivalence, n (%)
					< 80%	80–125%	> 125%
Morning fed (test) vs. morning fasted (reference) (B vs. A)
Cmax	40	38	79.0	75.4–82.8	20 (54.1)	16 (43.2)	1 (2.7)
AUC0–t	40	38	93.5	90.2–97.0	3 (8.1)	33 (89.2)	1 (2.7)
AUC0–∞	40	38	93.8	90.5–97.2	3 (8.1)	33 (89.2)	1 (2.7)
Evening fasted (test) vs. morning fasted (reference) (C vs. A)
Cmax	35	38	99.8	95.1–104.6	1 (2.9)	33 (94.3)	1 (2.9)
AUC0–t	35	38	110.2	106.2–114.3	0	31 (88.6)	4 (11.4)
AUC0–∞	35	38	109.8	105.9–113.9	0	31 (88.6)	4 (11.4)

A fasted in the morning (reference; morning fasted state), AUC_0–t area under the blood concentration-time curve from time 0 to time t, AUC_0–∞ area under the blood concentration-time curve from time 0 to infinity, B fed in the morning with a high-fat meal (test; morning fed state), C fasted in the evening (test; evening fasted state), CI confidence interval, C_max maximum observed drug concentration, GMR geometric mean ratio