Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study

Table 3 Artemether, lumefantrine and dihydroartemisinin: 90% CI for relevant PK parameters

Formulation	Analyte	PK	Geometric mean ratio
		variable	Estimate	Lower	Upper
		variable	Estimate	90% CI*	90% CI*
80/480 mg vs four standard tablets	Artemether	AUC_last	0.95	0.89	1.01
		C_max	0.97	0.89	1.06
		AUC_inf	0.95	0.89	1.02
	Lumefantrine	AUC_last	1.00	0.93	1.08
		C_max	0.97	0.89	1.05
		AUC_inf	1.00	0.92	1.09
	Dihydroartemisinin	AUC_last	0.98	0.93	1.04
		C_max	0.96	0.88	1.05
		AUC_inf	1.00	0.95	1.05
60/360 mg vs three standard tablets	Artemether	AUC_last	1.02	0.94	1.10
		C_max	1.06	0.95	1.18
		AUC_inf	1.00	0.93	1.09
	Lumefantrine	AUC_last	0.89	0.83	0.96
		C_max	0.87	0.81	0.94
		AUC_inf	0.89	0.83	0.96
	Dihydroartemisinin	AUC_last	1.00	0.94	1.07
		C_max	1.02	0.94	1.12
		AUC_inf	1.03	0.97	1.10

*CI confidence interval.
Model: The log transformed PK parameter data were analyzed using a linear model with treatment, sequence, period and subject nested within sequence as fixed factors.

ISSN: 1475-2875