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.
이용수
초록· 키워드
오류제보하기
Cefprozil is a broad-spectrum oral beta-lactam cephalosporin consisting of cis- and trans-isomeric mixture whose ratio is approximately 90:10. Cefprozil is used to treat certain infections caused by bacteria such as bronchitis and ear, skin,and throat infections. The purpose of the present study was to evaluate the bioequivalence of two cefprozil tablets,Cefzil® tablet 250 mg (BMS Pharmaceutical Korea., Ltd.) and Procezil tablet 250 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of cefprozil from the two cefprozil formulations were tested using KP VIII Apparatus I method with water dissolution media. Thirty five healthy male subjects, 24.00±1.53 years in age and 69.77±9.99 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After four tablets containing 1000 mg as cefprozil were orally administered,blood samples were taken at predetermined time intervals and the concentrations of cefprozil in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in water tested dissolution media. The pharmacokinetic parameters such as AUCt, Cmax and Tmax on the basis of total-cefprozil were calculated,and computer program (K-BE Test 2002) was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt, Cmax and untransformed Tmax. The results showed that the differences between two formulations based on the reference drug, Cefzil® tablets, were -0.81%, -3.00% and -6.83% for AUCt, Cmax and Tmax,respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.9515~log 1.0454and log 0.9613~log 1.0465 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procezil tablet was bioequivalent to Cefzil® tablet.
목차
등록된 정보가 없습니다.
참고문헌 (7)
참고문헌 신청
함께 읽어보면 좋을 논문
논문 유사도에 따라 DBpia 가 추천하는 논문입니다. 함께 보면 좋을 연관 논문을 확인해보세요!
-
레바미피드 100 mg 정제의 생물학적동등성
한국임상약학회지
2008 .01
-
탈리플루메이트 제제에 대한 생물학적동등성 평가
한국임상약학회지
2006 .01
-
밤벡® 정 10밀리그람(염산밤부테롤 10밀리그람)에 대한 밤부콜 정 10밀리그람의 생물학적동등성
한국임상약학회지
2010 .01
-
가바펜틴 800밀리그람 정제의 생물학적동등성시험
약학회지
2008 .01
-
한미염산펙소페나딘정120 mg의 생물학적 동등성
한국임상약학회지
2006 .01
-
모티리움엠정(말레인산 돔페리돈 12.72 mg)에 대한 디엠정의 생물학적동등성 평가
한국임상약학회지
2008 .01
-
니페디핀 서방정(니페디핀 33mg)의 생물학적 동등성
한국임상약학회지
2004 .01
-
에르도스테인 제제에 대한 생물학적동등성 평가
한국임상약학회지
2007 .01
-
비소프롤올 제제의 생물학적 동등성 평가
한국임상약학회지
2004 .01
-
로그변환 모델에 따른 생물학적 동등성 판정 연구
약학회지
2000 .01
-
라미실 정(테르비나핀 125mg)에 대한 터비넥스 정의 생물학적동등성
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
2003 .01
-
염산펙소페나딘 120밀리그람 정제의 생물학적동등성시험
약학회지
2008 .01
-
Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
2006 .01
-
레니프릴정(에날라프릴 10 mg)에 대한 에날라프릴정의 생물학적 동등성 평가
한국임상약학회지
2009 .01
-
Bioequivalence Study of Hydrocortisone Tablets while Secretion of Endogenous Cortisol Suppressed
Biomolecules & Therapeutics(구 응용약물학회지)
2008 .01
-
조프란 정(온단세트론 8mg)에 대한 온프란 정의 생물학적동등성
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
2003 .01
-
염산티로프라미드제제의 생물학적 동등성 평가
The journal of applied pharmacology : the official journal of the Korean Society of Applied Pharmacology
2000 .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
-
닛셀정에 대한 헤파필연질캡슐의 생물학적 동등성 평가
약학회지
2004 .01
-
Investigation of the Relationship Between In Vitro and In Vivo Release Behaviors of Acamprosate from Enteric-Coated Tablets
Archives of pharmacal research : a publication of the Pharmaceutical Society of Korea
2008 .01
이 논문의 저자 정보
최근 본 자료
댓글(0)
0