| Autor: |
Chunqi Huang, Yannan Wang, Yi Wu, Sisi Lin, Rui Hao, Jin Yu, Lu Fang, Jingjing Zhu, Di Zhao, Shengjia Tong, Yongkai Si, Tiantian Ye, Zeyu Wu, Hui Huang, Zhuoyan Wang, Ying Wang |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Precision Medical Sciences, Vol 11, Iss 4, Pp 186-194 (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2642-2514 |
| DOI: |
10.1002/prm2.12086 |
| Popis: |
Abstract Voriconazole is a first‐line medicine for treating invasive fungal infections. We evaluated the pharmacokinetics (PK) and safety of single/multiple doses of voriconazole injection of Hailing Pharmaceutical Group (Test, T), an imitation of Vfend® (Reference, R). Healthy subjects (n = 36) randomly received a once‐daily dose of T or R 3 or 4 mg/kg on Day 1 (single dose), a once‐daily dose of T or R 6 mg/kg on Day 4, and then six consecutive days for twice‐daily doses of T or R 3 or 4 mg/kg (multiple doses). The plasma was collected up to 72 h at time points after dosing on Day 1/10. Samples were measured by the liquid chromatography tandem mass spectrometry method. PK parameters were confirmed according to a non‐compartmental model. The relationship between the PK profiles of T and R revealed the different behavior in 3‐ and 4‐mg/kg groups. After single/multiple doses in the 3‐mg/kg group, the mean value for the area under the plasma concentration–time curve (AUC0−t, AUC0−∞) of R is about twice T. However, there was a high degree of similarity in the 4‐mg/kg group. The maximum plasma concentration (Cmax) of T and R showed no noticeable difference in the two groups. The median Tmax of T and R were within 2.0–2.13 h in the 3‐mg/kg group and 2.0–2.17 h in the 4‐mg/kg group. Severe adverse events did not occur. No clinically significant differences were found in safety and tolerance between T and R. This clinical study indicated that voriconazole injection might provide a safer alternative medicine. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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