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Featured researches published by Jicheng Yu.


Clinical Drug Investigation | 2012

Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses.

Beining Guo; Xiaojie Wu; Yingyuan Zhang; Yaoguo Shi; Jicheng Yu; Guoying Cao; Jing Zhang

AbstractBackground: Nemonoxacin, a novel C-8-methoxy non-fluorinated quinolone, is currently being developed in oral and intravenous formulations. It exhibits potent antibacterial activities against Gram-positive, Gram-negative and atypical pathogens, especially methicillin-resistant Staphylococcus aureus. The first-in-human study of a nemonoxacin capsule was conducted in a Western population. This current study was the first investigation on the clinical pharmacokinetics (PK) of nemonoxacin in a Chinese population, and was designed to determine PK data in a Chinese population and investigate the dose regimen for future clinical use. Objective: The objective of this study was to evaluate the PK profile of nemonoxacin as well as its safety and tolerability in healthy Chinese volunteers following single and multiple oral doses. Methods: The first part of the study was a double-blind, placebo-controlled, sequential ascending single-dose safety and tolerability study. In each cohort, two subjects received a placebo and six received single oral doses of nemonoxacin 125, 250, 500, 750 or 1000 mg. In the second part, the single-dose PK study, three dose levels (250, 500 and 750 mg) of nemonoxacin were administered orally to 12 healthy Chinese volunteers (male: female = 1:1) under fasting conditions in a crossover manner. The same volunteers received orally an additional dose of 500 mg under fed conditions after a 7-day washout. In the third part, the multiple-dose PK study, 24 subjects received 500 or 750 mg of nemonoxacin orally once daily for 10 consecutive days. Within each cohort, 12 subjects (male: female = 1:1) received the same dose level of nemonoxacin under fasting conditions. The PK profiles, safety and tolerability, and food and sex effects were evaluated. Results: No severe or serious adverse events (AEs) occurred in this study, and no clinically significant abnormalities were noted in the vital signs or on physical examination. Notable AEs, mainly nausea and rash with or without pruritus, were mild and resolved spontaneously. Most laboratory AEs were mild and transient and the subjects recovered without treatment. Nemonoxacin was found to be rapidly absorbed, with peak plasma concentrations (Cmax) attained 1–2 hours after administration. The Cmax and area under the concentration-time curve from time zero to infinity (AUC∞) were dose-proportional after single oral doses. The elimination half-life was 10–12 hours. Nemonoxacin was excreted primarily in urine, with a recovery of intact nemonoxacin of 60–70% of the dose over 72 hours. Food had a significant effect on the rate and extent of absorption (p<0.001), increasing the time to reach Cmax from 1.14 to 3.64 hours and reducing Cmax by 34% and AUC∞ by 18%, while a sex effect was not found. Cmax and AUC∞ were similar between the single-dose and multiple-dose PK studies. The multiple-dose PK data suggested no drug accumulation in healthy subjects. Conclusion: Nemonoxacin exhibited a linear PK profile in the 250–750 mg dose range with moderate food effects. There was no accumulation following consecutive administration for 10 days. The PK and safety profiles of nemonoxacin in Chinese subjects support evaluation of once-daily dosing in the future development of this agent.


Journal of Chromatography B | 2010

Liquid chromatography/tandem mass spectrometry assay for the simultaneous determination of cefoperazone and sulbactam in plasma and its application to a pharmacokinetic study

Yingjie Zhou; Jing Zhang; Beining Guo; Jicheng Yu; Yaoguo Shi; Minggui Wang; Yingyuan Zhang

A rapid and highly sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) method for simultaneous determination of cefoperazone sodium and sulbactam sodium in human plasma was developed. The analytes and internal standard (IS), cefuroxime sodium, were extracted from human plasma via liquid-liquid extraction with ethyl acetate and separated on a Waters Xterra C18 column within 3.5 min. Quantitation was performed on a triple quadrupole mass spectrometer employing electrospray ionization technique, operating in selected reaction monitoring (SRM) and negative ion mode. The precursor to product ion transitions monitored for cefoperazone, sulbactam and IS were m/z 644.1→528.0, 232.1→140.0, and 423.0→362.0, respectively. The assay was validated in the linear range of 0.1-20 μg/mL for cefoperazone and 0.02-4 μg/mL for sulbactam. The intra- and inter-day precisions (CV%) were within 8.39% for each analyte. The recoveries were greater than 87.3% for cefoperazone and 87.2% for sulbactam. Each analyte was found to be stable during all sample storage, preparation and analytical procedures. The method was successfully applied in a pharmacokinetic study of Sulperazon injection in six hospital-acquired pneumonia (HAP) patients.


Biomedical Chromatography | 2012

A liquid chromatography–tandem mass spectrometry assay for the determination of nemonoxacin (TG-873870), a novel nonfluorinated quinolone, in human plasma and urine and its application to a single-dose pharmacokinetic study in healthy Chinese volunteers

Beining Guo; Jing Zhang; Jicheng Yu; Xiaojie Wu; Yaoguo Shi; Cheng-yuan Tsai

Nemonoxacin (TG-873870) is a novel C-8-methoxy nonfluorinated quinolone with higher activity than ciprofloxacin, levofloxacin and moxifloxacin against Gram-positive pathogens including methicillin-susceptible or methicillin-resistant Staphylococcus aureus and Streptococcus pneumoniae with various resistant phenotypes. A rapid, sensitive and selective liquid chromatography-tandem mass spectrometric (LC-MS/MS) method was developed and validated to determine the concentration of nemonoxacin in human plasma and urine. Protein precipitation and liquid-liquid extraction were employed for plasma and urine sample preparations, respectively, and extract was then injected into the system. Separation was performed on a C(18) reversed-phase column using acetonitrile-0.1% formic acid as a mobile phase. Both analyte and internal standard (gatifloxacin) were determined using electrospray ionization and the MS data acquisition via the selected reaction monitoring in positive-ion mode. The lower limit of quantification was 5 ng/mL and the calibration curves were linear in the concentration range of 5-1000 ng/mL. The accuracy, precision, selectivity, linearity, recovery, matrix effect and stability were validated for TG-873870 in human plasma and urine. The method was successfully applied to a pharmacokinetic study enrolling 12 healthy Chinese volunteers administered nemonoxacin malate capsules.


Journal of Clinical Pharmacy and Therapeutics | 2013

Pharmacokinetics and pharmacodynamics of levofloxacin injection in healthy Chinese volunteers and dosing regimen optimization

Guoying Cao; Jiming Zhang; Xiaojie Wu; Jicheng Yu; Yuancheng Chen; Xinyu Ye; Demei Zhu; Y. Zhang; Beining Guo; Yongyong Shi

The pharmacokinetics (PK) and pharmacodynamics (PD) of levofloxacin were investigated following administration of levofloxacin injection in healthy Chinese volunteers for optimizing dosing regimen.


The Journal of Clinical Pharmacology | 2010

Permeability and Concentration of Levofloxacin in Epithelial Lining Fluid in Patients With Lower Respiratory Tract Infections

Jing Zhang; Xin Xie; Xin Zhou; Yu‐Qing Chen; Jicheng Yu; Guoying Cao; Xiaojie Wu; Yaoguo Shi; Yingyuan Zhang

The purpose of the study was to assess the bactericidal effects of a single oral dose of levofloxacin (LVFX) by examining the concentration of LVFX in alveolar epithelial lining fluid (ELF) from patients with lower respiratory tract infections (LRTI). Forty patients with LRTI took 500 mg of LVFX and then received a fiberoptic bronchoscopic procedure randomly 1, 4, 8, 12, or 24 hours following dosing. Bronchoalveolar lavage fluid and blood were collected at the time of the bronchopulmonary procedure, and the LVFX concentration was determined. The mean peak concentrations of LVFX in plasma and ELF were achieved at 1.5 hours (4.07 mg/L) and 1 hour (3.44 mg/L), respectively. The AUC24h samples were 50.12 mg · h/L and 34.51 mg · h/L, respectively. The permeability of LVFX, which was estimated based on the ratio of LVFX concentration in tissue fluids to that in plasma, was 0.78 on average across all time points. After a single dose of LVFX in patients with LRTI, the drug rapidly distributed into bronchopulmonary tissue, thereby suggesting this dose is capable of achieving the concentration in target organs required for bactericidal efficacy.


Therapeutic Drug Monitoring | 2014

Development and validation of a new ultra-performance liquid chromatographic method for vancomycin assay in serum and its application to therapeutic drug monitoring.

Yuran Cao; Jicheng Yu; Yuancheng Chen; Jing Zhang; Xiaojie Wu; Yingyuan Zhang; Guanghui Li

Objective: The aim of this study was to develop and validate an ultra-performance liquid chromatographic (UPLC) method with photodiode array detector for the measurement of vancomycin in human serum samples for therapeutic drug monitoring or other applications. Methods: The method included the extraction of vancomycin in serum by deproteinization with acetonitrile. The analyses were carried out using an ACQUITY UPLC BEH C18 column (2.1 × 50 mm, 1.7 &mgr;m) using acetonitrile and 0.005 M KH2PO4 buffer (pH 2.5) as the mobile phase at a flow rate of 0.3 mL/min, with photodiode array detection at 230 nm. The method was validated for extraction recovery, inter- and intraday precision (relative standard deviation, RSD%), and accuracy and stability of vancomycin in serum. Both the established UPLC method and fluorescence polarization immunoassay (FPIA) were used to measure the prepared quality control (QC) samples (1.0, 7.0, 35.0, 75.0 mg/L) to validate the accuracy of UPLC. Furthermore, both methods were subsequently used to assay the vancomycin concentration in 172 clinical serum samples collected from patients receiving vancomycin in the hospitals localized in Shanghai (China) and 32 control samples from United Kingdom National External Quality Assessment Service (UK NEQAS). Results: The retention time of vancomycin was 2.6 minutes. The calibration curve for UPLC was linear over the range 1.0–100.0 mg/L (R2 > 0.999). The method was fully validated in terms of recovery, selectivity, accuracy, precision, and various conditions. The absolute difference% and RSD% of the prepared QC samples assayed by UPLC were all better than the results by FPIA. A paired t test of the results of the prepared QC samples indicated that the results of all the QC samples had significant difference (P < 0.05), except for the 7.0 mg/L QC samples, which suggested that UPLC was more accurate for the samples containing low or high concentration of vancomycin. A correlation with the Deming model provided a good linear relation between the results of the 2 methods applied to 172 samples, with equation of UPLC = 0.99 × FPIA − 0.19 (R2= 0.923), and the agreement of the 2 methods was illustrated using Bland–Altman plot with a mean difference (UPLC − FPIA) of −0.428 mg/L and 95% confidence interval of −8.33 to 7.47 mg/L, respectively. A Student t test comparing results obtained by the UPLC method and group mean results of control samples from UK NEQAS were not significant (P = 0.057). Conclusions: A short analysis time, small amount of serum needed, high specificity, and accuracy make the UPLC method developed in this study appropriate and practical for vancomycin therapeutic drug monitoring and could be applied to other nonserum applications or where requiring superior validation parameters such as for pharmacokinetic/pharmacodynamic studies.


Journal of Chromatography B | 2014

Quantification of levornidazole and its metabolites in human plasma and urine by ultra-performance liquid chromatography–mass spectrometry

Yuran Cao; Miao Zhao; Xiaojie Wu; Beining Guo; Yuancheng Chen; Jicheng Yu; Guoying Cao; Jing Zhang; Yaoguo Shi; Yingyuan Zhang

We developed and validated an ultra-performance liquid chromatographic (UPLC) method coupled with atmospheric pressure chemical ionization (APCI) mass spectrometry for simultaneous determination of levornidazole and its first-pass metabolites, l-chloro-3-(2-hydroxymethyl-5-nitro-l-imidazolyl)-2-propanol (Ml), 2-methyl-5-nitroimidazole (M2) and 3-(2-methyl-5-nitro-1-imidazolyl)-1,2-propanediol (M4), in human plasma and urine. The biological samples were pretreated by protein precipitation and liquid-liquid extraction and analyzed using an ACQUITY UPLC CSH C18 column (2.1×50 mm, 1.7 μm) and a QTRAP mass spectrometer in multiple reaction monitoring mode via APCI. Acetonitrile and 0.1% formic acid in water was used as the mobile phase in gradient elution at a flow rate of 0.6 mL/min. The lower limit of quantification of this method was 0.0100, 0.00500, 0.0200 and 0.00250 μg/mL for levornidazole, M1, M2 and M4, respectively. The linear calibration curves were obtained for levornidazole, M1, M2, and M4 over the range of 0.0100-5.00, 0.00500-2.50, 0.0200-10.0 and 0.00250-1.25 μg/mL, respectively. The intra- and inter-batch precision was less than 12.2% in plasma and less than 10.8% in urine. The intra- and inter-batch accuracy was 87.8-105.7% in plasma and 92.8-109.2% in urine. The mean recovery of levornidazole, M1, M2 and M4 was 91.1-105.1%, 95.8-103.8%, 87.8-96.8%, 96.8-100.6% from plasma and 96.0-100.9%, 96.9-107.9%, 95.1-102.7%, 103.7-105.9% from urine respectively. This method was validated under various conditions, including room temperature, freeze-thaw cycles, long-term storage at -40 ± 5°C, after pretreatment in the autosampler (at 10°C), and 10- and 100-fold dilution. This newly established analytical method was successfully applied in a pharmacokinetic study following single intravenous infusion of levornidazole in 24 healthy Chinese subjects.


The Journal of Antibiotics | 2012

Establishment of norvancomycin fluorescence polarization immunoassay for therapeutic drug monitoring.

Xiaojie Wu; Jing Zhang; Jicheng Yu; Guoying Cao; Yaoguo Shi; Yingyuan Zhang; Minggui Wang

To establish a rapid and simple fluorescence polarization immunoassay method for determination of norvancomycin serum concentration, we collected 300 serum samples from the patients receiving norvancomycin in the hospitals localized in Shanghai, China. The drug concentrations were measured by the established HPLC method and FPIA with vancomycin kit. A FPIA algorithm for the determination of norvancomycin concentration was established according to the correlation between the FPIA and HPLC results. The methods and algorithm were validated in another 70 clinical samples. HPLC determination showed a good linear correlation within the range of 0.5–100 mg l−1 of norvancomycin concentrations. The method was validated via extraction recovery, intra- and inter-day methodological recovery and stability of norvancomycin in serum. Correlation analysis between the measurements of HPLC and FPIA in 300 serum samples gave the linear regression equation: (concentration by HPLC)=0.760 × (concentration by FPIA)–0.577 (P<0.001, R2=0.982). An algorithm was derived from this correlation for measuring the serum norvancomycin concentrations with FPIA. When it was validated in additional 70 serum samples from patients, ‘FPIA algorithm’ showed good accuracy versus HPLC: ‘FPIA algorithm’=0.93 (HPLC)+0.63, R2=0.962, and 94.3% of the results from FPIA algorithm fell within the range of −20%/+20% of HPLC. This algorithm developed in this study can be easily used for determination of norvancomycin using TDx analyzer with vancomycin kit indirectly. It may also be useful for norvancomycin therapeutic drug monitoring.


Antimicrobial Agents and Chemotherapy | 2016

Population Pharmacokinetics and Dosing Regimen Optimization of Meropenem in Cerebrospinal Fluid and Plasma in Patients with Meningitis after Neurosurgery

Cheng Lu; Y. Zhang; Mingyu Chen; Ping Zhong; Yuancheng Chen; Jicheng Yu; Xiaojie Wu; Jufang Wu; Jing Zhang

ABSTRACT Meropenem is used to manage postneurosurgical meningitis, but its population pharmacokinetics (PPK) in plasma and cerebrospinal fluid (CSF) in this patient group are not well-known. Our aims were to (i) characterize meropenem PPK in plasma and CSF and (ii) recommend favorable dosing regimens in postneurosurgical meningitis patients. Eighty-two patients were enrolled to receive meropenem infusions of 2 g every 8 h (q8h), 1 g q8h, or 1 g q6h for at least 3 days. Serial blood and CSF samples were collected, and concentrations were determined and analyzed via population modeling. Probabilities of target attainment (PTA) were predicted via Monte Carlo simulations, using the target of unbound meropenem concentrations above the MICs for at least 40% of dosing intervals in plasma and at least of 50% or 100% of dosing intervals in CSF. A two-compartment model plus another CSF compartment best described the data. The central, intercentral/peripheral, and intercentral/CSF compartment clearances were 22.2 liters/h, 1.79 liters/h, and 0.01 liter/h, respectively. Distribution volumes of the central and peripheral compartments were 17.9 liters and 3.84 liters, respectively. The CSF compartment volume was fixed at 0.13 liter, with its clearance calculated by the observed drainage amount. The multiplier for the transfer from the central to the CSF compartment was 0.172. Simulation results show that the PTAs increase as infusion is prolonged and as the daily CSF drainage volume decreases. A 4-hour infusion of 2 g q8h with CSF drainage of less than 150 ml/day, which provides a PTA of >90% for MICs of ≤8 mg/liter in blood and of ≤0.5 mg/liter or 0.25 mg/liter in CSF, is recommended. (This study has been registered at ClinicalTrials.gov under identifier NCT02506686.)


Journal of Clinical Pharmacy and Therapeutics | 2015

Vancomycin serum trough concentration vs. clinical outcome in patients with gram-positive infection: a retrospective analysis

Guoying Cao; X. Liang; Junwen Zhang; Y. Zhou; Jufang Wu; Y. Zhang; Yuancheng Chen; Jun Huang; Xiao-fang Liu; Jicheng Yu

Vancomycin is still the first‐line treatment for resistant gram‐positive infections, particularly for methicillin‐resistant Staphylococcus aureus (MRSA) infections. The vancomycin treatment guideline is based on the association between vancomycin trough concentration and clinical outcome. We here present a retrospective analysis of whether the trough level of vancomycin is associated with clinical outcome in Chinese patients with gram‐positive infections.

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