Bioequivalence of clavulanate potassium and amoxicillin (1:7) dispersible tablets in healthy volunteers / 华中科技大学学报(医学)(英德文版)
Journal of Huazhong University of Science and Technology (Medical Sciences)
;
(6): 224-227, 2002.
Artigo
em Inglês
| WPRIM
| ID: wpr-290552
ABSTRACT
To study the bioequivalence of Clavulanate Potassium and Amoxicillin (17) dispersible tablets, a randomized cross-over study was conducted in 18 healthy volunteers. A single oral dose of 1,000 mg Clavulanate Potassium and Amoxicillin (17) dispersible tablets (Tested formulation, T) or Augmentin syrup (Reference formulation, R). Concentrations in plasma were determined with high-performance liquid chromatography. The main parameters of T were for Clavulanate Potassium and Amoxicillin, Cmax 2.46 +/- 1.11 micrograms/ml and 18.81 +/- 7.26 micrograms/ml, Tmax 1.12 +/- 0.23 h and 1.30 +/- 0.34 h, AUC(0-6 h) 5.18 +/- 2.24 micrograms.h/ml and 45.09 +/- 14.53 micrograms.h/ml, t1/2 1.43 +/- 0.44 h and 1.09 +/- 0.22 h., respectively. The relative bioavailability of T to R were 96.5 +/- 19.2% and 98.4 +/- 26.1%, respectively. Statistical analysis showed that the two formulations were bioequivalent.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Comprimidos
/
Farmacocinética
/
Equivalência Terapêutica
/
Combinação Amoxicilina e Clavulanato de Potássio
/
Quimioterapia Combinada
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Adulto
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
Journal of Huazhong University of Science and Technology (Medical Sciences)
Ano de publicação:
2002
Tipo de documento:
Artigo
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