Early clinical development of artemether-lumefantrine dispersible tablet: palatability of three flavours and bioavailability in healthy subjects

Table 2 Relative bioavailability study - statistical analysis

	Parameter	Ratio (90% CI)*
*Treatment A (dispersible tablet) vs B (crushed tablet) (primary analysis)*
Artemether	AUC_0-inf AUC_0-tlast C_max	0.94 (0.86-1.02) 1.03 (0.94-1.13) 1.17 (1.06-1.29)
Dihydroartemisinin	AUC_0-inf AUC_0-tlast C_max	1.05 (0.99-1.11) 1.03 (0.93-1.15) 1.14 (1.04-1.24)
Lumefantrine	AUC_0-inf AUC_0-tlast C_max	0.90 (0.85-0.95) 0.89 (0.84-0.94) 0.91 (0.86-0.96)
*Treatment A (dispersible tablet) vs C (intact tablet) (secondary analysis)*
Artemether	AUC_0-inf AUC_0-tlast C_max	0.80 (0.71-0.90) 0.80 (0.73-0.88) 0.73 (0.65-0.82)
Dihydroartemisinin	AUC_0-inf AUC_0-tlast C_max	0.78 (0.72-0.84) 0.69 (0.62-0.77) 0.65 (0.58-0.73)
Lumefantrine	AUC_0-inf AUC_0-tlast C_max	1.06 (0.96-1.16) 1.12 (1.02-1.23) 1.07 (0.97-1.18)

*Ratio (90% CI) = ratio of the geometric means and 90% confidence interval for the comparison of Treatments A vs B and Treatments A vs C, respectively.
A single oral dose of 80 mg of artemether and 480 mg of lumefantrine (4 tablets) was administered to healthy adults as follows: Treatment A, fully dispersed in water; Treatment B, swallowed with water after crushing to coarse particles; Treatment C, swallowed with water without previous crushing.

ISSN: 1475-2875