Bioequivalence evaluation and food effect assessment of Lisinopril/amlodipine tablets in healthy Chinese subjects under fasting and fed conditions

Table 3 The geometric mean ratios of primary pharmacokinetic parameters for lisinopril and amlodipine and their 90%CIs under fasting and fed conditions

	Geometric mean		T/R (%)	Intra-CV (%)	90%CIs
	T	R	T/R (%)	Intra-CV (%)	90%CIs
Lisinopril, fasting
C_max(ng/mL)	50.71	51.12	99.19	24.3	90.54 ~ 108.67
AUC_0-t(h × ng/mL)	890.83	898.61	99.05	19.3	92.10 ~ 106.52
AUC_0-∞(h × ng/mL)	982.55	991.14	99.13	17.0	92.97 ~ 105.71
Amlodipine, fasting
C_max(ng/mL)	2.23	2.25	99.3	9.7	95.70 ~ 103.04
AUC_0-t (h × ng/mL)	112.1	113.27	98.97	9.9	95.30 ~ 102.78
AUC_0-∞(h × ng/mL)	120.52	121.66	99.07	10.5	95.19 ~ 103.04
Lisinopril, fed
C_max(ng/mL)	13.49	13.11	102.95	22.4	94.28 ~ 112.41
AUC_0-t(h × ng/mL)	376.67	383.16	98.31	13.3	93.28 ~ 103.61
AUC_0-∞(h × ng/mL)	483.99	484.98	99.79	12.9	94.83 ~ 105.02
Amlodipine, fed
C_max(ng/mL)	1.88	1.9	98.94	11.6	94.51 ~ 103.57
AUC_0-t (h × ng/mL)	105.04	112.61	93.28	9.3	89.92 ~ 96.77
AUC_0-∞(h × ng/mL)	114.06	122.33	93.24	9.8	89.67 ~ 96.65

Abbreviation: CI Confidence interval, Intra-CV Intra-subject coefficient of variation

ISSN: 2050-6511