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Therapeutic evaluation of sustained-releasing praziquantel (SRP) for clonorchiasis: phase 1 and 2 clinical studies
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Choi, M. H. | - |
dc.contributor.author | Chang, B. C. | - |
dc.contributor.author | Lee, S. J. | - |
dc.contributor.author | Jang, I. J. | - |
dc.contributor.author | Shin, S. G. | - |
dc.contributor.author | Kho, W. G. | - |
dc.contributor.author | Chun, J. H. | - |
dc.contributor.author | Hong, S. T. | - |
dc.date.accessioned | 2010-01-06 | - |
dc.date.available | 2010-01-06 | - |
dc.date.issued | 2006-12-16 | - |
dc.identifier.citation | Korean J Parasitol. 2006 Dec;44(4):361-6. | en |
dc.identifier.issn | 0023-4001 (Print) | - |
dc.identifier.uri | http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=17170578 | - |
dc.identifier.uri | https://hdl.handle.net/10371/25667 | - |
dc.description.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. | en |
dc.language.iso | en | en |
dc.publisher | Korean Society of Parasitology / The Korean Society for Parasitology | en |
dc.subject | Adult | en |
dc.subject | Animals | en |
dc.subject | Area Under Curve | en |
dc.subject | Clonorchiasis/*drug therapy | en |
dc.subject | Clonorchis sinensis/*drug effects/isolation & purification | en |
dc.subject | Humans | en |
dc.subject | Male | en |
dc.subject | Parasite Egg Count | en |
dc.subject | Anthelmintics/adverse effects/pharmacokinetics/therapeutic use | - |
dc.subject | Delayed-Action Preparations/pharmacokinetics/therapeutic use | - |
dc.subject | Praziquantel/adverse effects/pharmacokinetics/therapeutic use | - |
dc.title | Therapeutic evaluation of sustained-releasing praziquantel (SRP) for clonorchiasis: phase 1 and 2 clinical studies | en |
dc.type | Article | en |
dc.contributor.AlternativeAuthor | 최민호 | - |
dc.contributor.AlternativeAuthor | 장병찬 | - |
dc.contributor.AlternativeAuthor | 이성진 | - |
dc.contributor.AlternativeAuthor | 장인진 | - |
dc.contributor.AlternativeAuthor | 신상구 | - |
dc.contributor.AlternativeAuthor | 고원규 | - |
dc.contributor.AlternativeAuthor | 천진호 | - |
dc.contributor.AlternativeAuthor | 홍성태 | - |
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