지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2015.1
- 수록면
- 356 - 360 (5page)
이용수
초록· 키워드
오류제보하기
ObjectiveaaClozapine is the treatment of choice for refractory schizophrenia. The aim of this study was to compare the pharmacokinetics of the brand name (Clozaril) formulation and a generic formulation (Clzapine) of clozapine in Korean schizophrenic patients.
MethodsaaA prospective, randomized, crossover study was conducted to evaluate the steady-state pharmacokinetic profiles of Clozaril and Clzapine. Schizophrenic patients were randomized to receive either the brand name or generic formulation (100 mg twice daily) for 10 days, followed by the other formulation for 10 days. Plasma samples were collected on the last day of each treatment period.
ResultsaaTwenty-two of 28 patients (78.6%) completed the study. The mean Cmax,ss values for Clzapine and Clozaril were 524.62 and 551.18 ng/mL, and the mean AUC0-12 values were 4479.90 hr·ng/mL and 4724.56 hr·ng/mL, respectively. The 90% CI values for the natural logarithmically transformed Cmax,ss and AUC0-12 ratios (Clzapine to Clozaril) after a single oral dose (100 mg) were 0.934 (0.849–1.028) and 0.936 (0.869–1.008), respectively. Five patients (20.8%) among 24 patients who took Clzapine reported 11 adverse events and six adverse events were reported by four patients (15.4%) among 26 who took Clozaril; there were no significant differences on physical examination or in vital signs, ECG, and laboratory tests between groups.
ConclusionaaGeneric clozapine (Clzapine) appears to be bioequivalent to brand name clozapine (Clozaril).
목차
등록된 정보가 없습니다.
참고문헌 (18)
참고문헌 신청
Chaudhry IB / 2008 / Ethnicity and psychopharmacology / J Psychopharmacol 22 : 673 ~ 680
Desmarais JE / 2011 / Switching from brand-name to generic psychotropic medications: a literature review / CNS Neurosci Ther 17 : 750 ~ 760
Dold M / 2014 / Pharmacotherapy of treatment-resistant schizophrenia: a clinical perspective / Evid Based Ment Health 17 : 33 ~ 37
Fischer MA / 2003 / Economic consequences of underuse of generic drugs: evidence from Medicaid and implications for prescription drug benefit plans / Health Serv Res 38 : 105
Hopfinger AJ / 2009 / Findings of the challenge to predict aqueous solubility / J Chem Inf Model 49 : 1 ~ 5
Desmarais JE / 2011 / Switching from brand-name to generic psychotropic medications: a literature review / CNS Neurosci Ther 17 : 750 ~ 760
Dold M / 2014 / Pharmacotherapy of treatment-resistant schizophrenia: a clinical perspective / Evid Based Ment Health 17 : 33 ~ 37
Fischer MA / 2003 / Economic consequences of underuse of generic drugs: evidence from Medicaid and implications for prescription drug benefit plans / Health Serv Res 38 : 105
Hopfinger AJ / 2009 / Findings of the challenge to predict aqueous solubility / J Chem Inf Model 49 : 1 ~ 5
함께 읽어보면 좋을 논문
논문 유사도에 따라 DBpia 가 추천하는 논문입니다. 함께 보면 좋을 연관 논문을 확인해보세요!
-
Comparative Study of the Efficacy and Side Effects of Brand-Name and Generic Clozapine for Long-Term Maintenance Treatment Among Korean Patients With Schizophrenia: A Retrospective Naturalistic Mirror-Image Study
PSYCHIATRY INVESTIGATION
2024 .03
-
미국과 한국의 제네릭 의약품 활성화와 의약품 동등성 확보 정책에 대한 논의과정 비교
보건의료기술평가
2020 .01
-
A Multi-centric Bioequivalence Trial in Ph+ Chronic Myeloid Leukemia Patients to Assess Bioequivalence and Safety Evaluation of Generic Imatinib Mesylate 400 mg Tablets
Cancer Research and Treatment
2016 .01
-
A Brand New Year
소아청소년정신의학
2023 .01
-
Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study
Blood Research
2020 .01
-
Satisfaction Survey on Antipsychotic Formulations by Schizophrenia Patients in Japan
Clinical Psychopharmacology and Neuroscience
2021 .11
-
중약 제형의 연구동향
한약정보연구회지
2016 .11
-
Comparison of In Vivo Pharmacokinetics and Pharmacodynamics of Vancomycin Products Available in Korea
Yonsei Medical Journal
2020 .01
-
Efficacy of Asenapine in Schizophrenia Resistant to Clozapine Combined with Electroconvulsive Therapy: A Case Report
Clinical Psychopharmacology and Neuroscience
2019 .01
-
Clozapine Is Better Tolerated in Younger Patients: Risk Factors for Discontinuation from a Nationwide Database in Japan
PSYCHIATRY INVESTIGATION
2021 .01
-
A sensitive and fast HPLC method for determination of Isosorbide 5-mononitrate in human plasma using ion-pair chromatography: application to bioequivalence study
Journal of Pharmaceutical Investigation
2020 .01
-
"조현병 환자에서 노숙과 연관된 임상적 요인 : 사회적 기능을 중심으로"
신경정신의학
2015 .01
-
Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin
지질·동맥경화학회지
2020 .01
-
Evaluation of a spray-dried amorphous solid dispersion formulation of ID11916, a new molecular entity with dual inhibition mechanisms targeting the androgen receptor and phosphodiesterase type-5
Journal of Pharmaceutical Investigation
2024 .05
-
Comparison of circuit patency and exchange rates between the original and generic versions of nafamostat mesylate in critically ill adults receiving continuous renal replacement therapy
고신대학교 의과대학 학술지
2023 .03
-
Influence of clozapine on neurodevelopmental protein expression and behavioral patterns in animal model of psychiatric disorder induced by low-level of lead
The Korean Journal of Physiology & Pharmacology
2019 .01
-
Pharmacokinetics after Gastrectomy
대한외과학회 학술대회 초록집
2019 .10
-
대체육 안전관리 설정을 위한 기초연구
연구보고서
2022 .03
-
관해된 조현병 외래환자의 주 보호자의 부담요인
대한조현병학회지
2017 .10
-
Long-acting methylphenidate formulation in the treatment of ADHD
대한소아청소년정신의학회 학술대회논문집
2017 .05
이 논문의 저자 정보
최근 본 자료
댓글(0)
0