Pharmacokinetics and bioequivalence of ranitidine and bismuth derived from two compound preparations

Table 1 Pharmacokinetic parameters of ranitidine and bismuth after a single oral dose of compound ranitidine preparation (equivalent to 200 mg of ranitidine and 220 mg of bismuth) in 20 Chinese volunteers (mean ± SD)

Component	Parameters	Test	Reference
Ranitidine	Tmax (h)	2.3 ± 0.9	2.1 ± 0.9
	Cmax (mg/L)	0.67 ± 0.21	0.68 ± 0.22
	T1/2 (h)	2.8 ± 0.3	3.1 ± 0.4
	AUC(0-t) (mg/L per hour)	3.1 ± 0.6	3.0 ± 0.7
	AUC(0-∞) (mg/L per hour)	3.3 ± 0.6	3.2 ± 0.8
Bismuth	Tmax (h)	0.50 ± 0.20	0.50 ± 0.20
	Cmax (μg/L)	11.80 ± 7.36	11.40 ± 6.55
	T1/2 (h)	10.2 ± 2.3	13.0 ± 6.9
	AUC(0-t) (μg/L per hour)	46.65 ± 16.97	47.03 ± 21.49
	AUC(0-∞) (μg/L per hour)	55.38 ± 21.27	57.81 ± 23.31

Table 2 ANOVA for assessment of the drugs, subjects and period effects, and 90% CI for the test/reference ratio of C_max, AUC_(0-t) and AUC_(0-∞), using logarithmic transformed data, after administration of two compound ranitidine preparations (equivalent to 200 mg of ranitidine and 220 mg of bismuth) to 20 Chinese volunteers (ɑ= 0.05).

Component	Parameters	ANOVA (P-value)			90% CI (%)
		Variation source
		Drug	Subjects	Period
Ranitidine	Cmax	0.9191	0.0686	0.7679	86.7-113.6
	AUC(0-t)	0.3917	0.0153	0.8366	96.0-113.4
	AUC(0-∞)	0.4733	0.02118	0.9064	95.3-112.5
Bismuth	Cmax	0.65695	0.51515	0.39551	89.8-120.0
	AUC(0-t)	0.66066	0.11347	0.71245	88.1-124.0
	AUC(0-∞)	0.75149	0.15804	0.87169	85.3-111.5