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서지반출
건강한 한국인 자원자에서 리스페리돈 구강붕해 제제인 리스페달오디$^{(R)}$정 1mg과 리스페달 퀵릿$^{(R)}$정 1mg의 생물학적동등성 연구
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  • 건강한 한국인 자원자에서 리스페리돈 구강붕해 제제인 리스페달오디$^{(R)}$정 1mg과 리스페달 퀵릿$^{(R)}$정 1mg의 생물학적동등성 연구
저자명
강가은,김진,배경열,신희영,정성욱,윤진상,김종근,Kang. Ga-Eun,Kim. Jin,Bae. Kyung-Yeol,Shin. Hee-Young,Jeong. Seong-Wook,Yoon. Jin-Sang,Kim. Jong-Keun
간행물명
臨床藥理學會誌= The journal of Korean Society for Clinical Pharmacology and Therapeutics
권/호정보
2011년|19권 1호|pp.31-39 (9 pages)
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대한임상약리학회
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

Background: Risperidone is one of the atypical antipsychotic drugs that have effectiveness in the management of a range of psychiatric illnesses. Orally disintegrating (OD) formulations of risperidone that rapidly dissolve in the mouth, prior to swallowing without water have been developed to overcome any problems related to swallowing and improve acceptability. The goal of this study was to evaluate the bioequivalence of Risperdal OD$^{(R)}$ tablet 1mg and Quicklet$^{(R)}$ tablet 1mg Methods: This randomized, open-label, 2-way crossover trial was conducted in 36 healthy male volunteers that received OD risperidone tablet, either the reference formulation (Risperdal Quicklet$^{(R)}$tablet 1mg), or the test formulation (Risperdal OD$^{(R)}$ tablet 1mg), each in a single administration. Blood samples were obtained during a 24-hour period after dosing. Plasma was analyzed for risperidone by a validated LC-MS/MS. Adverse events were monitored by safety assessments including clinical interview by clinician. Pharmacokinetics were calculated by noncompartmental analysis and compared between two formulations Results: A total of 36 male volunteers (mean age, 24.2 years; height 174.5 cm; weight 67.6 kg) completed the study. The ANOVA showed no significant effect of sequence, formulation and period of Ln ($AUC_{last}$) and Ln ($C_{max}$). The 90 % confidence intervals for the mean treatment ratios of the Ln (AUClast) and Ln ($C_{max}$) were Ln 0.96 ~ Ln 1.12, Ln 0.97 ~ Ln 1.16, respectively. No serious adverse events were caused by both formulations. Conclusion: In this study, a single administration of Risperdal OD$^{(R)}$ tablet 1mg was bioequivalent to a single administration of Risperdal Quicklet$^{(R)}$ tablet 1mg.