|
KMID : 0369820050350040295
|
|
Jorunal of Korean Pharmaceutical Sciences
2005 Volume.35 No. 4 p.295 ~ p.301
|
|
|
Bioequivalence of Famcivir Tablet to Famvir(TM) Tablet 250 mg (Famciclovir 250 mg)
|
|
강현아/Kang HA
조혜영/오인준/이명희/이용복/Cho HY/Oh IJ/Lee MH/Lee YB
|
|
|
Abstract
|
|
|
|
Famciclovir is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, FamvirTM tablet 250 mg (Novartis Korea Ltd.) and Famcivir (Hanmi Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, 24.19±2.08 years in age and 71.55±6.89 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After a single tablet containing 250 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at water. In addition, the pharmacokinetic parameters such as AUCt, Cmax and Tmax were calculated and ANOVA test 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, FamvirTM tablet 250 mg, were -2.93, -8.02 and 10.47% 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 log0.8 to log1.25 (e.g., log0.92∼log1.01 and log0.85∼log1.00 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir was bioequivalent to FamvirTM tablet 250 mg.
|
|
|
KEYWORD
|
|
|
Famciclovir, Famvir, Famcivir, Bioequivalence, HPLC
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|