Bioequivalence evaluation of orally disintegrating tablet of pentoxyverine citrate.
- Author:
Ming-qin LIN
1
;
Ying CAI
;
Wei ZHANG
;
Xiu-qiong WU
;
Jin-jun RAO
;
Shu-wen LIU
Author Information
- Publication Type:Journal Article
- MeSH: Adult; Area Under Curve; Biological Availability; Citric Acid; administration & dosage; pharmacokinetics; Cross-Over Studies; Cyclopentanes; administration & dosage; pharmacokinetics; Humans; Male; Tablets; Therapeutic Equivalency; Young Adult
- From: Journal of Southern Medical University 2010;30(7):1621-1623
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the bioequivalence of orally disintegrating tablets of pentoxyverine citrate (tested preparation) in healthy male volunteers.
METHODSA 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.
RESULTSThe 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.
CONCLUSIONThe tested and reference preparations are bioequivalent.
