Bioequivalence and pharmacokinetic evaluation of two formulations of glimepiride 2 mg: A single-dose, randomized-sequence, open-label, two-way crossover study in healthy chinese male volunteers

Liu, Yun; Mengqi, Zhang; Zhu, Jie; Jia, Jingying; Liu, Yanmei; Liu, Gangyi; Li, Shuijun; Weng, Liping; Chen, Yu

doi:10.1016/j.clinthera.2010.04.016

Cited by 9 publications

(10 citation statements)

References 16 publications

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“…The corresponding values for the active metabolite of RIS in the participants were 2.56 ± 0.60 L/kg and 2.67 ± 0.79 mL/min kg. The values reported for these pharmacokinetic parameters were comparable to previously reported ones (Liu et al, 2013). The profile of mean plasma concentration of RIS and 9-OHRIS vs time is shown in Fig.…”

Section: Applicability Of the Validated Methodssupporting

confidence: 89%

Concurrent determination of olanzapine, risperidone and 9‐hydroxyrisperidone in human plasma by ultra performance liquid chromatography with diode array detection method: application to pharmacokinetic study

Kumar¹,

Ramanathan²

2015

Biomedical Chromatography

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A simple and sensitive ultra-performance liquid chromatography (UPLC) method has been developed and validated for simultaneous estimation of olanzapine (OLZ), risperidone (RIS) and 9-hydroxyrisperidone (9-OHRIS) in human plasma in vitro. The sample preparation was performed by simple liquid-liquid extraction technique. The analytes were chromatographed on a Waters Acquity H class UPLC system using isocratic mobile phase conditions at a flow rate of 0.3 mL/min and Acquity UPLC BEH shield RP18 column maintained at 40°C. Quantification was performed on a photodiode array detector set at 277 nm and clozapine was used as internal standard (IS). OLZ, RIS, 9-OHRIS and IS retention times were found to be 0.9, 1.4, .1.8 and 3.1 min, respectively, and the total run time was 4 min. The method was validated for selectivity, specificity, recovery, linearity, accuracy, precision and sample stability. The calibration curve was linear over the concentration range 1-100 ng/mL for OLZ, RIS and 9-OHRIS. Intra- and inter-day precisions for OLZ, RIS and 9-OHRIS were found to be good with the coefficient of variation <6.96%, and the accuracy ranging from 97.55 to 105.41%, in human plasma. The validated UPLC method was successfully applied to the pharmacokinetic study of RIS and 9-OHRIS in human plasma.

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Section: Applicability Of the Validated Methodssupporting

confidence: 89%

Concurrent determination of olanzapine, risperidone and 9‐hydroxyrisperidone in human plasma by ultra performance liquid chromatography with diode array detection method: application to pharmacokinetic study

Kumar¹,

Ramanathan²

2015

Biomedical Chromatography

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“…Accordingly, AUC t and C max of the products A and B (Tables 4 and 5) were within the predefined bioequivalence acceptance limits (80-125%, 90% CI). [15] Table 6 summarizes Wilcoxon signed test of T max , summarized in Table 6, suggests that both of the products can be considered bioequivalent with Mobic â .…”

Section: Bioequivalence Study In Beagle Dogsmentioning

confidence: 99%

Evaluating bioequivalence of meloxicam tablets: is in-vitro dissolution test overdiscriminating?

Jin

Zhao

Shen

et al. 2018

Journal of Pharmacy and Pharmacology

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“…It should also be noted that the results of some of the bioequivalence studies are published in peer-reviewed journals with high impact factor (e.g. Clinical Therapeutics, Drugs) [6,7].…”

Section: Bioequivalence Studiesmentioning

confidence: 99%

“…Należy też podkreślić, że wyniki niektó-rych badań biorównoważności są publikowane w czasopismach recenzowanych, często mających wysoki współczyn-nik odziaływania (np. ,,Clinical Therapeutics'', ,,Drugs'') [6,7].…”

Section: Badania Równoważności Biologicznejunclassified

Bioequivalence and therapeutic equivalence of psychotropic drugs

Cessak¹,

Rokita²,

Bałkowiec-Iskra³

2015

Postępy Psychiatrii i Neurologii

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Bioequivalence and pharmacokinetic evaluation of two formulations of glimepiride 2 mg: A single-dose, randomized-sequence, open-label, two-way crossover study in healthy chinese male volunteers

Cited by 9 publications

References 16 publications

Concurrent determination of olanzapine, risperidone and 9‐hydroxyrisperidone in human plasma by ultra performance liquid chromatography with diode array detection method: application to pharmacokinetic study

Concurrent determination of olanzapine, risperidone and 9‐hydroxyrisperidone in human plasma by ultra performance liquid chromatography with diode array detection method: application to pharmacokinetic study

Evaluating bioequivalence of meloxicam tablets: is in-vitro dissolution test overdiscriminating?

Bioequivalence and therapeutic equivalence of psychotropic drugs

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