[Bioequivalence evaluation of orally disintegrating tablet of pentoxyverine citrate].
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.
Lin
Ming-qin
MQ
School of Pharmaceutical Sciences, Southern Medical University, Guangzhou 510515, China. lin-mingqin@163.com
Cai
Ying
Y
Zhang
Wei
W
Wu
Xiu-qiong
XQ
Rao
Jin-jun
JJ
Liu
Shu-wen
SW
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
D003517:Cyclopentanes; D013607:Tablets; D019343:Citric Acid; C018861:carbetapentane