Journal of Bioequivalence & Bioavailability

The Government Pharmaceutical Organization, 75/1 Rama VI Road, Ratchathewi, Bangkok 10400, Thailand

Publications

• Research Article   
  Bioequivalence Study of Entecavir 0.5 mg Tablets in Healthy Thai Volunteers Under Fasting Conditions
  Author(s): Vipada Khaowroongrueng*, Charinthon Seeduang, Suchada Rakphung, Mariam Duereh, Lalinthip Saeaue, Busarat Karachot, Isariya Techatanawat, Porranee Puranajoti and Praphassorn Surawattanawan
  
  Entecavir is a nucleoside polymerase inhibitor indicated for chronic hepatitis B infection in order to minimize the development of serious consequences. The Government Pharmaceutical Organization (GPO), Thailand has developed HEPA-EN®, entecavir 0.5 mg tablets as a generic substitute for the corresponding innovator product, Baraclude® (Bristol-Myers Squibb Company, USA) to enhance patient adherence to continuous treatment. The bioequivalence study was conducted under fasting conditions using a randomized-sequence, open-label, 2-period crossover design. The plasma samples were collected for 72 hours in both study periods and analyzed using a validated liquid chromatography tandem mass spectrometry method. The 90% CIs of the geometric least squares mean ratio between the formulations of log-transformed AUC0-72h and Cmax were.. View more»
  

  DOI: 10.35248/0975-0851.22.14.448

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