Journal of Bioequivalence & Bioavailability

Piyapat Pongnarin

Publications

• Research Article
  Bioequivalence Study of 10 mg Olanzapine Tablets in Healthy Thai Volunteers
  Author(s): Somruedee Chatsiricharoenkul, Suvimol Niyomnaitham, Piyapat Pongnarin, Korbtham Sathirakul and Supornchai KongpatanakulSomruedee Chatsiricharoenkul, Suvimol Niyomnaitham, Piyapat Pongnarin, Korbtham Sathirakul and Supornchai Kongpatanakul
  
  Objective: The purpose of this study was to compare the bioequivalence of 10 mg tablets of olanzapine between a generic drug (Olapin ® -10; Unison Laboratories Co., Ltd., Thailand) and a reference drug (Zyprexa ® ,Eli Lilly, England) in healthy volunteers. Subjects and methods: A single dose, randomized, 2-period, 2-sequence, crossover study was conducted in 24 healthy Thai male and female volunteers. Each volunteer received a 10 mg tablet of the reference or test drug under fasting condition with a washout period of at least 21 days. Blood samples were obtained at pre-dose and at various time points up to 120 hours after dosing. Olanzapine plasma concentrations were quantified by a validated method employing liquid chromatography with tandem mass spectrometry (LC-MS/MS). Results: 24 volunteers completed both treatment periods. The geometric mean ratios (GMR) (test/reference) .. View More»
  DOI: 10.4172/jbb.1000064

  Abstract PDF