Therapeutic evaluation of sustained-releasing praziquantel (SRP) for clonorchiasis: Phase 1 and 2 clinical studies.
10.3347/kjp.2006.44.4.361
- Author:
Min Ho CHOI
1
;
Byung Chan CHANG
;
Seung Jin LEE
;
In Jin JANG
;
Sang Goo SHIN
;
Weon Gyu KHO
;
Jin Ho CHUN
;
Sung Tae HONG
Author Information
1. Department of Parasitology and Tropical Medicine and Institute of Endemic Diseases, Seoul National University College of Medicine, Seoul, 110-799, Korea. hst@snu.ac.kr
- Publication Type:Original Article ; Clinical Trial, Phase I ; Clinical Trial, Phase II ; Research Support, Non-U.S. Gov't
- Keywords:
Clonorchis sinensis;
clonorchiasis;
clinical study;
human;
praziquantel;
sustained-release;
cure rate
- MeSH:
*Praziquantel/adverse effects/pharmacokinetics/therapeutic use;
Parasite Egg Count;
Male;
Humans;
*Delayed-Action Preparations/pharmacokinetics/therapeutic use;
Clonorchis sinensis/*drug effects/isolation & purification;
Clonorchiasis/*drug therapy;
Area Under Curve;
*Anthelmintics/adverse effects/pharmacokinetics/therapeutic use;
Animals;
Adult
- From:The Korean Journal of Parasitology
2006;44(4):361-366
- CountryRepublic of Korea
- Language:English
-
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.
