Therapeutic evaluation of sustained-releasing praziquantel (SRP) for clonorchiasis: Phase 1 and 2 clinical studies
The Korean Journal of Parasitology
;
: 361-366, 2006.
Artigo
em Inglês
| WPRIM
| ID: wpr-220302
ABSTRACT
Sustained-releasing praziquantel (SRP) tablet was designed for single dose treatment regimen of clonorchiasis. A previous pre-clinical study confirmed its sustained-releasing characteristics and a better cure rate than conventional praziquantel (PZQ). In this clinical study, the pharmacokinetics of this SRP tablet were investigated in human volunteers (phase 1; 12 volunteers), and its curative efficacy was examined in clonorchiasis patients (phase 2; 20 volunteers). In the phase 1 clinical study, blood concentrations of both tablets showed wide individual variation. The AUC(last) of SRP was 497.9+/-519.0 ng.hr/ml (mean+/-SD) and PZQ of 628.6+/-695.5 ng.hr/ml, and the AUC(inf) of SRP was 776.0+/-538.5 ng.hr/ml and of PZQ 658.6+/-709.9 ng.hr/ml. C(max) values of SRP and PZQ were 90.7+/-82.2 ng/ml and 214.9+/-251.9 ng/ml, and T(max) values were 3.42+/-1.43 hr and 1.96+/-1.23 hr, respectively. SRP tablets showed similar AUC values, but lower C(max) and longer T(max) values than PZQ. In the phase 2 study, SRP at 30 mg/kg (single dose) achieved a 60% cure rate and a 95.5% egg reduction rate. The cure rate of a single dose SRP was unsatisfactory compared with that of the conventional PZQ dose, but much better than that achieved by a single dose PZQ.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Contagem de Ovos de Parasitas
/
Praziquantel
/
Clonorquíase
/
Clonorchis sinensis
/
Área Sob a Curva
/
Preparações de Ação Retardada
/
Anti-Helmínticos
Tipo de estudo:
Estudo prognóstico
Limite:
Animais
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
The Korean Journal of Parasitology
Ano de publicação:
2006
Tipo de documento:
Artigo
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