Bioequivalence study of voriconazole for intravenous infusion in healthy Chinese subjects under fasting conditions

Voriconazole, a second-generation triazole, is used to prevent and treat invasive fungal infections. This study aimed to assess the bioequivalence and safety of test and reference voriconazole intravenous infusion under the fasting conditions. The study employed a randomized, open-label, single-dose...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences Vol. 114; no. 2; p. 1385
Main Authors: Xiang, Zhangqiang, Li, Mupeng, Cui, Shaoting, Gan, Chunyan, Liu, Fangfang, Huang, Qian, Mai, Gang, Fan, Lianlian
Format: Journal Article
Language:English
Published: United States 01.02.2025
Subjects:
Adult
Antifungal Agents - administration & dosage
Antifungal Agents - adverse effects
Antifungal Agents - blood
Antifungal Agents - pharmacokinetics
Area Under Curve
Asian People
Cross-Over Studies
East Asian People
Fasting - blood
Female
Healthy Volunteers
Humans
Infusions, Intravenous
Male
Middle Aged
Tandem Mass Spectrometry - methods
Therapeutic Equivalency
Voriconazole - administration & dosage
Voriconazole - adverse effects
Voriconazole - blood
Voriconazole - pharmacokinetics
Young Adult
Safety
Bioequivalence
Pharmacokinetics
Chinese subjects
Voriconazole
ISSN:1520-6017, 1520-6017
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Summary:Voriconazole, a second-generation triazole, is used to prevent and treat invasive fungal infections. This study aimed to assess the bioequivalence and safety of test and reference voriconazole intravenous infusion under the fasting conditions. The study employed a randomized, open-label, single-dose, two-period, crossover trial design. Eligible subjects randomly assigned for screening, receiving either the test or reference voriconazole for intravenous infusion during the first period, with alternative products administered during the second period. The washout period lasted 7 days. The single administration dosage was fixed at 6 mg/kg. Nineteen blood samples were collected at pre-dose and up to 46 h post-dose for each subject. The validated LC-MS/MS method was used to determine the concentration of voriconazole in plasma. Twenty-four subjects were enrolled in the study, comprising 20 males and 4 females. The primary pharmacokinetic parameters (mean ± SD) were as follows: C was 4631.20 ± 744.80 and 5008.09 ± 1020.77 ng/mL, AUC was 27,121.07 ± 12,658.03 and 28,674.08 ± 13,118.05 ng*h/mL, and AUC was 28,056.10 ± 14,428.76 and 29,616.29 ± 14,783.70 ng*h/mL for the test and reference formulations, respectively. The 90 % confidence intervals of geometric mean ratios for C , AUC , and AUC fell within the range of 80.00 % to 125.00 %. Both products were well tolerated and no serious adverse event was observed. The test and reference voriconazole intravenous infusion demonstrated bioequivalence and good tolerability.
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ISSN:1520-6017
1520-6017
DOI:10.1016/j.xphs.2024.12.012