Pharmacokinetics and bioequivalence of domestic trimetazidine formulations / 中华心血管病杂志
Chinese Journal of Cardiology
; (12): 1041-1044, 2012.
Artigo
em Chinês
| WPRIM (Pacífico Ocidental)
| ID: wpr-292045
Biblioteca responsável:
WPRO
ABSTRACT
<p><b>OBJECTIVE</b>To compare the pharmacokinetics and bioequivalence between domestic hydrochloric trimetazidine capsules and imported hydrochloric trimetazidine tablets in healthy male Chinese volunteers after single oral administration.</p><p><b>METHODS</b>A single oral dose (test and reference formulations) was given to 24 healthy male Chinese subjects according to an open randomized crossover design. The blood samples were collected before and after administration. Plasma trimetazidine concentration was determined by HPLC-MS/MS. The pharmacokinetic parameters were calculated by WinNonlin Ver 6.2.1 software.</p><p><b>RESULTS</b>The main pharmacokinetic parameters of domestic and imported formulation of trimetazidine were similar C(max) (70.9 ± 15.3), (66.4 ± 13.8) µg/ml; t(max) (1.70 ± 0.72), (1.85 ± 0.55) h; t(1/2z) (4.70 ± 1.75), (4.77 ± 1.96) h; AUC(0-24 h) (481 ± 176), (469 ± 171) µg×h×ml(-1); AUC(0-∞) (511 ± 189), (500 ± 188) µg×h×ml(-1). The estimated 90% CIs for the ratio of C(max) and AUC(0-24 h) were also similar 101.9% - 112.5% and 99.4% - 104.9%. The relative bioavailability of domestic formulation was (102.2 ± 8.3)%.</p><p><b>CONCLUSION</b>The results demonstrates that the domestic hydrochloric trimetazidine capsules and imported hydrochloric trimetazidine tablets are bioequivalent.</p>
Texto completo:
Disponível
Base de dados:
WPRIM (Pacífico Ocidental)
Assunto principal:
Plasma
/
Trimetazidina
/
Sangue
/
Farmacocinética
/
Equivalência Terapêutica
/
Química
/
Estudos Cross-Over
/
Metabolismo
Tipo de estudo:
Ensaio clínico controlado
Limite:
Adulto
/
Humanos
/
Masculino
Idioma:
Chinês
Revista:
Chinese Journal of Cardiology
Ano de publicação:
2012
Tipo de documento:
Artigo