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

doi:10.5497/wjp.v12.i1.1

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Feb 17, 2023 (publication date) through Nov 7, 2024

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World Journal of Pharmacology

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2220-3192

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Randomized Clinical Trial

World J Pharmacol. Feb 17, 2023; 12(1): 1-11
Published online Feb 17, 2023. doi: 10.5497/wjp.v12.i1.1

Table 2 Mean pharmacokinetic parameters for test and reference product (R1 and R2) for itraconazole

Variable	mean ± SD
Variable	Test (T)	Reference (R1)	Reference (R2)
C_max (ng/mL)	132.12 (65.31)	308.57 (173.63)	136.90 (67.91)
AUC_0-t	2738.083 (1164.121)	4953.205 (2472.121)	3065.766 (1295.989)
AUC_0-inf	3109.578 (1342.394)	5744.760 (2917.508)	3614.170 (1850.356)
T_max	11.45(6.05)	6.00 (1.49)	10.85 (6.33)
Kel	0.022 (0.007)	0.021 (0.007)	0.023 (0.008)
t_1/2	34.89 (13.18)	37.83 (14.95)	35.16 (20.14)
Residual area	11.92 (7.41)	12.86 (7.86)	12.22 (9.10)

SD: Standard deviation; 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.

Citation: Naqvi SMH, Gala MYN, Muchhala S, Arumugam A, Panigrahi D, Patil D, Rathod R, Mane A. Pharmacokinetics/Pharmacodynamics study of Fixtral SB as compared to supra bioavailable itraconazole and conventional itraconazole. World J Pharmacol 2023; 12(1): 1-11
URL: https://www.wjgnet.com/2220-3192/full/v12/i1/1.htm
DOI: https://dx.doi.org/10.5497/wjp.v12.i1.1