A novel self-micro-emulsifying delivery system (SMEDS) formulation significantly improves the fasting absorption of EPA and DHA from a single dose of an omega-3 ethyl ester concentrate

Table 6 Baseline-corrected dose normalized total DHA AUC_0-24h and C_max

Study	Treatment	Dose normalized parameter	Arithmetic mean ± SD (N)	Geometric mean (N)	Ratio of dose normalized geometric mean^b
Study	Treatment	Dose normalized parameter	Arithmetic mean ± SD (N)	Geometric mean (N)	N	Ratio PRF-021: Control	Lower 95% CI	Upper 95% CI
1	PRF-021	AUC_0-24h/D μg*h/mL/g	383.2 ± 202.8 (20)	325 (20)	20	3.63	2.57	5.14
	Control	AUC_0-24h/D μg*h/mL/g	122.2 ± 93.10 (20)	89.5 (20)	20	3.63	2.57	5.14
	PRF-021	C_max/D μg/mL/g	33.4 ± 20.9 (20)	34.3 (20)	20	2.68	2.09	3.44
	Control	C_max/D μg/mL/g	7.95 ± 5.68 (20)	12.8 (20)	20	2.68	2.09	3.44
2	PRF-021	AUC_0-24h/D μg*h/mL/g	328.9 ± 195.1 (39^a)	266 (39)	39	5.61	3.97	7.92
	Control	AUC_0-24h/D μg*h/mL/g	70.70 ± 53.88 (40)	48.1 (40)	39	5.61	3.97	7.92
	PRF-021	C_max/D μg/mL/g	28.2 ± 20.4 (39^a)	36.4 (39^a)	39	4.29	3.31	5.55
	Control	C_max/D μg/mL/g	3.88 ± 4.56 (40)	8.50 (40)	39	4.29	3.31	5.55

^aOne subject withdrawn ^bRatios calculated in subjects with complete dataset only

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