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Therapeutic evaluation of sustained-releasing praziquantel (SRP) for clonorchiasis: phase 1 and 2 clinical studies

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Authors
Choi, M. H.; Chang, B. C.; Lee, S. J.; Jang, I. J.; Shin, S. G.; Kho, W. G.; Chun, J. H.; Hong, S. T.
Issue Date
2006-12-16
Publisher
Korean Society of Parasitology / The Korean Society for Parasitology
Citation
Korean J Parasitol. 2006 Dec;44(4):361-6.
Keywords
AdultAnimals*Anthelmintics/adverse effects/pharmacokinetics/therapeutic useArea Under CurveClonorchiasis/*drug therapyClonorchis sinensis/*drug effects/isolation & purification*Delayed-Action Preparations/pharmacokinetics/therapeutic useHumansMaleParasite Egg Count*Praziquantel/adverse effects/pharmacokinetics/therapeutic use
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 AUClast of SRP was 497.9 +/- 519.0 ng * hr/ml (mean +/- SD) and PZQ of 628.6 +/- 695.5 ng * hr/ml, and the AUCinf of SRP was 776.0 +/- 538.5 ng * hr/ml and of PZQ 658.6 +/- 709.9 ng * hr/ml. Cmax values of SRP and PZQ were 90.7 +/- 82.2 ng/ml and 214.9 +/- 251.9 ng/ml, and Tmax values were 3.42 +/- 1.43 hr and 1.96 +/- 1.23 hr, respectively. SRP tablets showed similar AUC values, but lower Cmax and longer Tmax 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.
ISSN
0023-4001 (Print)
Language
English
URI
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17170578

http://hdl.handle.net/10371/25667
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College of Medicine/School of Medicine (의과대학/대학원)Pharmacology (약리학전공)Journal Papers (저널논문_약리학전공)
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