Table 4.

7.2 and 0.72% oral powder formulation bioavailability: Study 2 point estimates and 90% CIs

Study regimen description	Pharmacokinetic parametersa	Central valueb		Relative bioavailability
		Test	Reference	Point estimatec	90% CI
7.2% oral powder (high fat) versus 100 mg tablet (high fat)	Cmax	0.740	0.863	0.857	0.777–0.946
	AUCt	11.7	10.5	1.109	1.056–1.164
	AUC∞	12.0	10.8	1.107	1.053–1.162
7.2% oral powder (high fat) versus 7.2% oral powder (fasted)	Cmax	0.740	0.313	2.361	2.045–2.727
	AUCt	11.7	4.01	2.915	2.595–3.274
	AUC∞	12.0	4.18	2.871	2.559–3.221
0.72% oral powder (high fat) versus 100 mg tablet (high fat)	Cmax	0.690	0.863	0.799	0.724–0.881
	AUCt	11.3	10.5	1.074	1.022–1.128
	AUC∞	11.6	10.8	1.071	1.019–1.125
0.72% oral powder (high fat) versus 0.72% oral powder (fasted)	Cmax	0.690	0.263	2.617	2.267–3.022
	AUCt	11.3	3.67	3.085	2.747–3.465
	AUC∞	11.6	3.82	3.035	2.705–3.405

Note: High-fat meals consisted of 800–1000 Kcal with ~ 50% of the caloric intake from fat

AUC_∞ area under the plasma concentration–time curve from time zero to infinite time, AUC_t area under the plasma concentration–time curve from time zero to time of the last measurable concentration, CIs confidence intervals, C_max maximum observed plasma concentration

^aUnits for C_max and AUC are expressed as μg/mL and μg⋅h/mL, respectively

^bAnti-logarithm of the least squares means for logarithms

^cAnti-logarithm of the difference (test minus reference) of the least squares means of the logarithms