Journal of Bioequivalence & Bioavailability

Xuewen Qiu

Publications

• Research Article
  Pharmacokinetics and Bioequivalence Evaluation of Two Voriconazole tablets: an Open-Label, Single-Dose, Randomized, Two-Way Crossover Study in Healthy Chinese Male Volunteers
  Author(s): Xuewen Qiu, Rongfeng Xiang, Qing Dai, Bo Yang, Lirong Xiong, Yangjing Ou, Min Tang and Yongchuan ChenXuewen Qiu, Rongfeng Xiang, Qing Dai, Bo Yang, Lirong Xiong, Yangjing Ou, Min Tang and Yongchuan Chen
  
  The aim of this study was to assess and compare the pharmacokinetic properties, bioavailability, and bioequivalence of a newly developed tablet of voriconazole with those of an established branded formulation in healthy Chinese adult male volunteers. An open-label, single-dose, randomized, 2-way crossover study was conducted in fasted healthy Chinese male volunteers. Eligible participants were randomly assigned in a 1:1 ratio to receive one tablet (200 mg) of the test or reference formulations, followed by a 1-week washout period and administration of the alternate formulations. Plasma samples were collected over 36 hours and analyzed by HPLC. The Voriconazole plasma concentration–time curves were used to obtain pharmacokinetic parameters including AUC0–t, AUC0–∞, Cmax and Tmax. The criteria for bioequivalence were 90% CIs of 80% to 125% for AUC and 70%.. View More»
  DOI: 10.4172/jbb.10000110

  Abstract PDF