|
KMID : 0614020040190010057
|
|
Journal of Pharmaceutical Sciences (C.N.U.)
2004 Volume.19 No. 1 p.57 ~ p.63
|
|
|
Bioequivalence of Vidcef capsule to Duricef capsule(Cefadroxil 500 mg)
|
|
Kim Hye-Jin
Lee Tae-Wan
Hwang Sung-Joo
Yu Jin-Hee
Lee Si-Beum
|
|
|
Abstract
|
|
|
|
The purpose of the present study was to evaluate the bioequivalence of two cefadroxil capsules, test drug(Vidcef capsule Yuyu Inc.) and reference drug(Duricef capsule Bo Ryung Pharmaceutical Co, Ltd.), according to the guidelines of Korea Food and Drug Administration(KFDA). Twenty four healthy male volunteers, 23.21±2.92 year in age and 67.46±5.47 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two capsules containing 1000 mg of cefadroxil were orally administered, blood sample were taken at the scheduled time intervals and the scheduled time intervals and the concentrations of cefadroxil in plasma were determined using HPLC with UV detector. The dissolution profiles of two cefadroxil capsules were very similar at all dissolution media. Pharmacokinetic parameters such as AUC_(t), C_(max) and T_(max) were calculated and ANOVA test was used for the statistical analysis of the parameters using logarithmically transformed AUC_(t) and C_(max) and untransformed T_(max). These results showed that the differences between two formulations were 0.06%-2.26% and 8.17% for AUC_(t), C_(max) and T_(max), respectively. There were no sequence effects between the two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25(log 0.94∼log1.09 and log0.90∼log.1.06 for AUC_(t) and C_(max) respectively). Thus, the criteria of the KFDA guidelines for the bioequivalence were satisfied, indicating Duricef capsule and Vidcef capsule are bioequivalent.
|
|
|
KEYWORD
|
|
|
Cefadroxil, Duricef, Vidcef, Bioequivalence, HPLC
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|