Bioequivalence evaluation of orally disintegrating tablet of pentoxyverine citrate / 南方医科大学学报
Journal of Southern Medical University
;
(12): 1621-1623, 2010.
Artigo
em Chinês
| WPRIM
| ID: wpr-336124
ABSTRACT
<p><b>OBJECTIVE</b>To evaluate the bioequivalence of orally disintegrating tablets of pentoxyverine citrate (tested preparation) in healthy male volunteers.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>The tested and reference preparations are bioequivalent.</p>
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Comprimidos
/
Farmacocinética
/
Disponibilidade Biológica
/
Equivalência Terapêutica
/
Estudos Cross-Over
/
Ácido Cítrico
/
Área Sob a Curva
/
Ciclopentanos
Tipo de estudo:
Ensaio Clínico Controlado
/
Estudo prognóstico
Limite:
Adulto
/
Humanos
/
Masculino
Idioma:
Chinês
Revista:
Journal of Southern Medical University
Ano de publicação:
2010
Tipo de documento:
Artigo
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