title: [Bioequivalence evaluation of orally disintegrating tablet of pentoxyverine citrate].
abstract: OBJECTIVE
  To evaluate the bioequivalence of orally disintegrating tablets of pentoxyverine citrate (tested preparation) in healthy male volunteers.
  
  
  METHODS
  A single oral dose of the tested and reference preparations at 25 mg were given to 20 healthy volunteers in a randomized two-period cross-over design. Plasma pentoxyverine citrate concentrations were determined by HPLC-MS/ESI+ method. The pharmacokinetic parameters were calculated and the bioequivalence of the two preparations were evaluated using DAS program.
  
  
  RESULTS
  The Tmax, Cmax, AUC0 15 and AUC0infinity of tested and reference preparations were 1.62-/+0.75 h and 2.52-/+1.21 h, 62.28-/+33.06 microg/L and 59.72-/+33.25 microg/L, 234.44-/+130.01 microg.h.L(-1) and 228.77-/+129.24 microg.h.L(-1), 246.80-/+136.19 microg.h.L(-1) and 244.11-/+140.73 microg.h.L(-1), respectively. The 90% confidence interval of C(max), AUC0 15 and AUC0infinity of tested preparations were 81.4%-138.4%, 86.0%-123.3% and 86.5%-121.2%, respectively.
  
  
  CONCLUSIONS
  The tested and reference preparations are bioequivalent.
authors.affiliation: School of Pharmaceutical Sciences, Southern Medical University, Guangzhou 510515, China. lin-mingqin@163.com
authors.forename: Ming-qin
authors.initials: MQ
authors.lastname: Lin
authors.forename: Ying
authors.initials: Y
authors.lastname: Cai
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Xiu-qiong
authors.initials: XQ
authors.lastname: Wu
authors.forename: Jin-jun
authors.initials: JJ
authors.lastname: Rao
authors.forename: Shu-wen
authors.initials: SW
authors.lastname: Liu
mesh_terms: D000328:Adult; D019540:Area Under Curve; D001682:Biological Availability; D019343:Citric Acid / Q000008:administration & dosage / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D003517:Cyclopentanes / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency; D055815:Young Adult
chemical_list: D003517:Cyclopentanes; D013607:Tablets; D019343:Citric Acid; C018861:carbetapentane