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Bioequivalence Study of Two Favipiravir Tablet Formulations in Healthy Male Subjects
  • +7
  • Onursal Sağlam,
  • Gökçe Demiray,
  • Berrak Güney,
  • Emel Doğan-Kurtoğlu,
  • Merve Ulusoy,
  • Nihal Saraner,
  • Gamze Sevici,
  • Muradiye Nacak,
  • Aydın Erenmemişoğlu,
  • Vildan Tüzer
Onursal Sağlam
Novagenix Bioanalytical Drug R&D Center
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Gökçe Demiray
Novagenix Bioanalytical Drug R&D Center
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Berrak Güney
Novagenix Bioanalytical Drug R&D Center
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Emel Doğan-Kurtoğlu
Novagenix Bioanalytical Drug R&D Center
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Merve Ulusoy
Novagenix Bioanalytical Drug R&D Center
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Nihal Saraner
Novagenix Bioanalytical Drug R&D Center
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Gamze Sevici
Novagenix Bioanalytical Drug R&D Center
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Muradiye Nacak
FARMAGEN-Good Clinical Practice Center
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Aydın Erenmemişoğlu
Alpan Farma R&D Biotechnologies Ltd
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Vildan Tüzer
Atabay Pharmaceutıcals And Fıne Chemıcals Inc
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Abstract

Abstract Background: As WHO expresses, COVID-19 is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. COVID-19 is now a pandemic affecting many countries globally. Antiviral agents play fundamental role in Covid-19 treatment. Favipiravir is one of the favored agents and it still draws attention of generic drug industry which is constitutional for drug accessibility. Objective: The aim of this study is to demonstrate the bioequivalence of a new Favipiravir tablet formulation as compared to the reference tablet formulation in healthy male subjects under fasting conditions.To prove the bioequivalence, a randomised, single oral dose, cross-over, two-period study was carried out in 30 healthy subjects under fasting conditions. Plasma Favipiravir levels were quantified by using an in-house-developed high performance Liquid Chromatography Coupled to Tandem Mass Spectrometry (LC-MS/MS) method. Results: The 90% CIs for the test/reference geometric mean ratios of the Cmax and AUC0-tlast were 92.92 – 119.89% and 94.00 – 99.77%, respectively. Conclusions: This single-dose study has shown that the test and reference Favipiravir products met the required bioequivalence criteria. Besides, both products were well tolerated and safe. *The data that support the findings of this study are available from the corresponding author upon reasonable request. Some data may not be made available because of privacy or ethical restrictions.