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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| Published in: | Journal of pharmaceutical sciences Vol. 114; no. 2; p. 1385 |
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| Main Authors: | , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
01.02.2025
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| ISSN: | 1520-6017, 1520-6017 |
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| Abstract | 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. |
|---|---|
| AbstractList | 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. 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.OBJECTIVEVoriconazole, 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.METHODSThe 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: Cmax was 4631.20 ± 744.80 and 5008.09 ± 1020.77 ng/mL, AUC0-t was 27,121.07 ± 12,658.03 and 28,674.08 ± 13,118.05 ng*h/mL, and AUC0-∞ 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 Cmax, AUC0-t, and AUC0-∞ fell within the range of 80.00 % to 125.00 %. Both products were well tolerated and no serious adverse event was observed.RESULTSTwenty-four subjects were enrolled in the study, comprising 20 males and 4 females. The primary pharmacokinetic parameters (mean ± SD) were as follows: Cmax was 4631.20 ± 744.80 and 5008.09 ± 1020.77 ng/mL, AUC0-t was 27,121.07 ± 12,658.03 and 28,674.08 ± 13,118.05 ng*h/mL, and AUC0-∞ 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 Cmax, AUC0-t, and AUC0-∞ 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.CONCLUSIONThe test and reference voriconazole intravenous infusion demonstrated bioequivalence and good tolerability. |
| Author | Liu, Fangfang Gan, Chunyan Li, Mupeng Mai, Gang Cui, Shaoting Huang, Qian Xiang, Zhangqiang Fan, Lianlian |
| Author_xml | – sequence: 1 givenname: Zhangqiang surname: Xiang fullname: Xiang, Zhangqiang organization: Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan 618000, China – sequence: 2 givenname: Mupeng surname: Li fullname: Li, Mupeng organization: Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan 618000, China – sequence: 3 givenname: Shaoting surname: Cui fullname: Cui, Shaoting organization: Hunan Sailong Pharmaceutical (Changsha) Co., Ltd, Changsha, Hunan 410199, China – sequence: 4 givenname: Chunyan surname: Gan fullname: Gan, Chunyan organization: Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan 618000, China – sequence: 5 givenname: Fangfang surname: Liu fullname: Liu, Fangfang organization: Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan 618000, China – sequence: 6 givenname: Qian surname: Huang fullname: Huang, Qian organization: Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan 618000, China – sequence: 7 givenname: Gang surname: Mai fullname: Mai, Gang email: stdygcp@163.com organization: Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan 618000, China. Electronic address: stdygcp@163.com – sequence: 8 givenname: Lianlian surname: Fan fullname: Fan, Lianlian email: 510791761@qq.com organization: Phase 1 Clinical Trial Center, Deyang People's Hospital, Deyang, Sichuan 618000, China. Electronic address: 510791761@qq.com |
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| Keywords | Safety Bioequivalence Pharmacokinetics Chinese subjects Voriconazole |
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| SubjectTerms | 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 |
| Title | Bioequivalence study of voriconazole for intravenous infusion in healthy Chinese subjects under fasting conditions |
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