Pharmacokinetics/Pharmacodynamics study of Fixtral SB as compared to supra bioavailable itraconazole and conventional itraconazole

Table 1 Summary of pharmacokinetic variables determining bioequivalence for itraconazole – Test vs reference product (R2)

Variable	Geometric mean		T/R2 ratio (%), 90%CI	Outcome of BE result
	Test (T)	Reference (R2)
AUC0-t (ng × h/mL)	2533.47	2794.45	0.9066 (83.31% - 98.65%)	Bioequivalent
AUC0-inf (ng × h/mL)	2856.78	3212.68	0.8892 (81.57%– 96.92%)	Bioequivalent
Cmax (ng/mL)	117.4	118.82	0.988 (88.57%-110.22%)	Bioequivalent

T: Test; R2: Reference; BE: Bioequivalence; CI: Confidence interval; AUC_0-t: Area under the concentration-time curve over the dosing interval; AUC_0-inf: Area under the curve; C_max: Maximum concentration; T_max: Time to peak drug concentration.