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

Table 1 Baseline demographic characteristics

Sequence	Fasting study (n = 40)	Fed study (n = 51)	Total	P
Age(years)	28.1 ± 7.7	31.0 ± 9.0	29.7 ± 8.5	0.11
Male/Female	30/10	38/13	62/23	0.96
Height(cm)	169.0 ± 9.1	169.7 ± 7.5	169.4 ± 8.2	0.69
Weight(kg)	63.4 ± 8.9	64.4 ± 8.2	64.0 ± 8.5	0.58
BMI(kg/m²)	22.1 ± 1.9	22.3 ± 2.0	22.2 ± 1.9	0.63
PR(beats/min)	74.7 ± 9.7	75.1 ± 11.5	74.9 ± 10.7	0.86
SBP(mmHg)	121.2 ± 10.9	121.7 ± 12.2	121.5 ± 11.6	0.84
DBP(mmHg)	72.5 ± 7.5	73.0 ± 7.7	72.7 ± 7.6	0.76

Notes: T, test formulation, compound lisinopril tablet (lisinopril /amlodipine besylate 10 mg /5 mg); R, reference formulation, Lisonorm® (lisinopril /amlodipine besylate 10 mg /5 mg); P-values were determined by independent t test
Abbreviation: BMI Body mass index, PR Pulse rate, SBP Systolic blood pressure, DBP Diastolic blood pressure

ISSN: 2050-6511