Journal of Bioequivalence & Bioavailability

Rita Grace Alvero

Publications

• Research Article
  Bioequivalence of Omeprazole Delayed-Release Capsules in Healthy Filipino Subjects
  Author(s): Qinying Zhao, Anna Plotka, Grace Encelan- Brizuela, Cynthia Ernst, Jason Gobey, Pamela Johnson, Bernadette Dela Rosa, Rita Grace Alvero and Bharat DamleQinying Zhao, Anna Plotka, Grace Encelan- Brizuela, Cynthia Ernst, Jason Gobey, Pamela Johnson, Bernadette Dela Rosa, Rita Grace Alvero and Bharat Damle
  
  Study background: Omeprazole is indicated for the treatment of various acid-related gastrointestinal disorders. It is acid labile and therefore administered orally as enteric-coated granules in capsules. Methods: This randomized, open-label, single dose, two-way cross-over clinical pharmacology study in healthy adult Filipino subjects evaluated the bioequivalence of a new 40 mg delayed-release (enteric-film coated) capsule formulation of omeprazole (Pfizer Inc., US) relative to the reference marketed Losec® capsule (2x20 mg; AstraZeneca, Sweden; enteric-coated granules in capsule) under fasted conditions. Pharmacokinetic blood sampling was carried out at various time points for 12 h post-dose and plasma samples were analysed using a fully validated ultra performance liquid chromatography with tandem Mass Spectrometry technology. The primary endpoints were area under plasma concen.. View More»
  DOI: 10.4172/jbb.10000195

  Abstract PDF