Journal of Bioequivalence & Bioavailability

Leonid Nikolaevich Shitov

Publications

• Research Article
  The Pharmacokinetic Properties and Bioequivalence of Methyldopa Formulations: Results of an Open-label, Randomized, Two-period, Crossover, Single-dose Study
  Author(s): Alexander Leonidovich Khokhlov, Leonid Nikolaevich Shitov, Miroslav Ryska, Yuriy Aleksandrovich Dzhurko, Vladimír Kube&scaron, Vitaliy Nikolaevich Shabrov, Aleksey Evgenyevich Miroshnikov, Elena Valeryevna Korneva, Anna Vitalyevna Demchinskaya, Anastasiya Mikhailovna Shitova, Igor Evgenyevich Shokhin and Elena Georgievna LileevaAlexander Leonidovich Khokhlov, Leonid Nikolaevich Shitov, Miroslav Ryska, Yuriy Aleksandrovich Dzhurko, Vladimír Kube&scaron, Vitaliy Nikolaevich Shabrov, Aleksey Evgenyevich Miroshnikov, Elena Valeryevna Korneva, Anna Vitalyevna Demchinskaya, Anastasiya Mikhailovna Shitova, Igor Evgenyevich Shokhin and Elena Georgievna Lileeva
  
  Comparative assessment of the pharmacokinetic properties and bioequivalence (BE) of two methyldopa formulations (Methyldopa, 250 mg tablets, R-Pharm CJSC, Russia-investigational medicinal product, and Dopegyt®, 250 mg tablets, EGIS Pharmaceuticals PLC, Hungary-reference product) were investigated in 24 healthy volunteers (13 women and 11 men, caucasian) in an open-label, randomized, crossover, two-period, two-sequence trial with 7-day washout period. A comparative dissolution test was carried out in advance in 3 media, including quantitative determination of methyldopa by UV spectrophotometry. The release patterns of the active ingredient from the test and reference products were equivalent. Methyldopa concentrations in plasma were measured by validated method of high-performance liquid chromatography-tandem mass spectrometry, using the deuterated internal standard. The validation.. View More»
  

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