Pharmacokinetic profile of novel multi-layer stable effervescent tablet: a cross-over study with an established European brand in healthy young male adults

Table 2 Shows a statistical comparison of test and reference products for the area under the curve till time t, maximum plasma concentration achieved, and time to reach maximum plasma concentration

Variables	Drug	N	Mean ± Std. deviation	Std. error mean	Significance*	TR ratio**
AUC (µg.h/ml)	Test	12	27.12 ± 6.02	1.74	t = 0.089, p = 0.93	0.99
AUC (µg.h/ml)	Reference	12	27.29 ± 2.64	0.76	t = 0.089, p = 0.93	0.99
C_max (µg/ml)	Test	12	7.42 ± 1.06	0.31	t = 0.89, p = 0.38	0.95
C_max (µg/ml)	Reference	12	7.83 ± 1.19	0.34	t = 0.89, p = 0.38	0.95
T_max (hr)	Test	12	0.85 ± 0.22	0.06	t = 0.22, p = 0.83	1.02
T_max (hr)	Reference	12	0.83 ± 0.25	0.07	t = 0.22, p = 0.83	1.02

*p-value is considered significant at < 0.05; ** TR = Test to Reference (Recommended Range 0.80–1.25)

ISSN: 2050-6511