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Loxoprofen sodium 제제(레녹스정)의 생물학적 동등성시험

Other Titles
 Bioequivalence Study of Loxoprofen Sodium in healthy Volunteers 
Authors
 최주영  ;  유내춘  ;  박민수  ;  김경환 
Citation
 Journal of Applied Pharmacology (응용약물학회지), Vol.6(4) : 417-422, 1998 
Journal Title
 Journal of Applied Pharmacology (응용약물학회지) 
ISSN
 1225-6110 
Issue Date
1998
Abstract
Loxoprofen sodium (sodium 2-[4-(2-oxocyclopentylmethyl)phenyl] propionate dehydrate) is a nonsteroidal antiinflammatory drug of α-phenyl propionic acid derivative. To test the bioequivalence of loxoprofen, the pharmacokinetic parameters of new preparation of loxoprofen, LENOX was compared with LOXONIN as a reference drug. Fourteen healthy volunteers were entered to the stydy (Yonsei University College of Medicine, Severance Hospital IRB approval No. 9608). They were administered 60 mg of loxoprofen in 2x2 cross-over design. There was one week of drug-free interval between doses. The blood sample was taken on schedule up to 8 hours, and the plasma concentration loxoprofen was measured by reverse phase high-performance liquid chromatography (HPLC) with UV-detector. There were no significant difference between two preparations when AUC, Cmax, and Tmax were compared by ANOVA. The mean differences of AUC, Cmax, and Tmax were within 20% of the reference drug: the values were 2.22,5.61, and 12.50%, respectively. The confidence limits of AUC and Cmax but not Tmax satisfied the bioequivalence criteria. These results suggest that the tested LENOX is bioequivalent to the reference drug.
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Kyung Hwan(김경환)
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
Yoo, Nae Choon(유내춘)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/176377
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