Journal of Bioequivalence & Bioavailability

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

Publications

• Research Article   
  Bioequivalence Study of Quetiapine 25 mg Tablets in Healthy Thai Volunteers under Fasting Conditions
  Author(s): Ekawan Yoosakul, Vipada Khaowroongrueng*, Jaturavit Vattanarongkup, Charinthon Seeduang, Nava Suthepakul, Busarat Karachot, Isariya Techatanawat, Praphassorn Surawattanawan and Porranee Puranajoti
  
  A comparative randomized, single-dose, two-way crossover, open-label study was carried out to assess bioequivalence and tolerability of test (Quapine®) and reference (Seroquel®) products of quetiapine 25 mg tablets in healthy Thai volunteers. Forty-four male and female subjects were enrolled in the study. Blood samples were collected at predefined time points over 48 hours after oral administration. Plasma concentrations of quetiapine were determined using a validated Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS). The pharmacokinetic parameters were calculated for the test and reference products using non-compartmental analysis. Bioequivalence between the products was determined by calculating 90% Confidence Intervals (CIs) for the geometric least squares mean ratio of log-transformed primary parameters (AUC0-tlast.. View more»
  

  DOI: 10.35248/0975-0851.22.14.478

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