TABLE 3.

Pharmacokinetic profile following administration of a single dose of standard, phase 1, or phase 2 amoxicillin-clavulanate formulation^a

Parameter	A/C formulation and single-dose size of each A/C component
	Standard formulationb (600 mg amoxicillin/42.9 mg clavulanate/5 ml); amoxicillin, 45 mg/kg/dose	Phase 1 formulationc (600 mg amoxicillin/21.5 mg clavulanate/5 ml); amoxicillin, 45 mg/kg/dose	Phase 2 formulationc (600 mg amoxicillin/21.5 mg clavulanate/5 ml); amoxicillin, 40 mg/kg/dose	Standard formulationb (600 mg amoxicillin/42.9 mg clavulanate/5 ml); clavulanate, 3.2 mg/kg/dose	Phase 1 formulationc (600 mg amoxicillin/21.5 mg clavulanate/5 ml); clavulanate, 1.6 mg/kg/dose	Phase 2 formulationc (600 mg amoxicillin/21.5 mg clavulanate/5 ml); clavulanate, 1.425 mg/kg/dose
Cmax (μg/ml)—mean ± SD	15.7 ± 7.7	15.3	13.0 ± 0.5	1.7 ± 0.9	2.1	1.13 ± 0.4
Tmax (h)—mean (range)	2.0 (1.0–4.0)	1.5	2.9 (2.8–2.9)	1.1 (1.0–4.0)	1.5	2.0 (1.9–2.1)
AUC0–t (μg · h/ml)—mean ± SD	59.8 ± 20.0	77.4	55.3	4.0 ± 1.9	4.9	3.8
t1/2 (h)—mean ± SD	1.4 ± 0.3	4.2	1.9	1.1 ± 0.3	2.9	1.4
CL/F (liters/h/kg)—mean ± SD	0.9 ± 0.4	0.5	0.69	1.1 ± 1.1	0.31	0.37

^aA/C, amoxicillin-clavulanate. C_max, maximum serum concentration. T_max, time after administration when the maximum serum concentration was reached. AUC_0–t, area under the plasma concentration-time curve from the beginning to the end of the dosing interval (in the present study, 12 h). In the present study, the last actual sample was obtained 4 h after administration of medication, and the AUC from 4 to 12 h after administration was projected using the estimated terminal half-life. t_1/2, half-life. CL/F, apparent total clearance of the drug from plasma after oral administration.

^bData taken from the Augmentin prescribing information.

^cWhere SD and range are not provided, data were obtained from a single sample or a composite analysis using multiple data points (t_1/2; AUC; CL/F).