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Pharmacokinetics of levornidazole disodium phosphate in monkey
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Qian ZHAO1, Li-li LI1, Pei HU1, Wen ZHONG1, Fei DING2, Shu-tian JIA2, Zheng-fang HU2, Wen-bo LIU2, Ji JIANG1, *
Acta Pharmaceutica Sinica | 2018, 53(1) : 90 - 96
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Acta Pharmaceutica Sinica | 2018, 53(1): 90-96
• ORIGINAL ARTICLES •
Pharmacokinetics of levornidazole disodium phosphate in monkey
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Qian ZHAO1, Li-li LI1, Pei HU1, Wen ZHONG1, Fei DING2, Shu-tian JIA2, Zheng-fang HU2, Wen-bo LIU2, Ji JIANG1, *
Affiliations
  • 1. Clinical Pharmacology Research Centre & Translational Medicine Centre, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
  • 2. Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd, Nanjing 210000, China
Published: 2018-01-12 doi: 10.16438/j.0513-4870.2017-0996
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This study was carried out to investigate the pharmacokinetics/bioequivalence of levornidazole disodium phosphate by using stable isotope labeled drug, evaluated the pharmacokinetic profile and confirmed the prodrug characteristics of levornidazole disodium phosphate in monkey. Levornidazole (Drug A) and stable isotope 15N labeled levornidazole disodium phosphate (Drug B) were mixed with equal mole amount (experiment Ⅰ); stable isotope 15N labeled levornidazole disodium phosphate (Drug B) and levornidazole disodium phosphate (Drug C) were mixed with equal mole amount, respectively. After giving the mixed drugs to the monkey, the concentration of 15N-levornidazole disodium phosphate, levornidazole disodium phosphate, 15N-levornidazole and levornidazole in plasma samples of pre-dosing and 24 h after administration were analyzed by a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method. Pharmacokinetic calculations were performed through non-compartmental analysis using WinNonlin software. Two-sided 90% confidence intervals (CI) were used to evaluate the bioequivalence of two drugs. The results showed that levornidazole disodium phosphate was metabolized to levornidazole rapidly after administration, the body exposure were increased with the dosage. The method of bioequivalence used in this study was different from the traditional two periods, crossover design. By using the method of this study, the effects of administration period, intra-individual variability, and sequence of administration on bioequivalence were avoided. The results of this study had successfully supported the pharmacokinetic and bioequivalence study of this drug in human using the same approach.

levornidazole disodium phosphate  /  levornidazole  /  stable isotope labeled drug  /  bioequiva-lence  /  pharmacokinetics
Qian ZHAO, Li-li LI, Pei HU, Wen ZHONG, Fei DING, Shu-tian JIA, Zheng-fang HU, Wen-bo LIU, Ji JIANG. Pharmacokinetics of levornidazole disodium phosphate in monkey[J]. Acta Pharmaceutica Sinica, 2018 , 53 (1) : 90 -96 . DOI: 10.16438/j.0513-4870.2017-0996
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Article Info
doi: 10.16438/j.0513-4870.2017-0996
  • Receive Date：2017-10-12
  • Online Date：2026-01-15
  • Published：2018-01-12
Article Data
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History
  • Received：2017-10-12
  • Revised：2017-12-12
Funding
Affiliations
    1. Clinical Pharmacology Research Centre & Translational Medicine Centre, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
    2. Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co., Ltd, Nanjing 210000, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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