|
KMID : 0370020020160000055
|
|
Chung-Ang Journal of Pharmacal Sciences
2002 Volume.16 No. 0 p.55 ~ p.65
|
|
|
Determination of Cimetidine in human plasma and Bioequivalence of Cimetidine Preparations
|
|
|
|
|
Abstract
|
|
|
|
Cimetidine is a histamine H_2-receptor antagonist, used for the treatment of endoscopically or radiographically conformed duodenal ulcer, pathologic GI hypersecretory condition, and active, benign, gastric ulcer. Simple method for determining of cimetidine in human plasma has been developed and validated. The procedure was linear in the range from 0.05 to 2 ug/mL for cimetidine. The intraday and interday validation for coefficient of variance (CV, %) and relative error (RE, %) were less than ±15%. Based on this analysis method, the bioequivalence of two cimetidine 400 mg tablet reference (Tagamet^® 400mg) and test drug (AK-Cimetidine 400 mg) was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers, 66.79±7.98 kg in body weight and 23±2.73 in age, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 400 mg of cimetidine was orally administered, blood samples were taken at the predetermined time intervals and the concentrations of cimetidine in plasma were determined by protein precipitation method using HPLC with UV detector. Pharmacokinetic parameters such as AUC and Cmax were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in AUC and Cmax between two tablets were 1.3 % and 3.4 % respectively. The 90% confidence intervals for these parameters were also within ±20 % (e.g., log 0.9510∼log 1.0259 and log 0.9369∼log 1.1417 for AUC, Cmax, respectively). All of the above mentioned parameters met the criteria of KFDA guidelines for bioequivalence indicating that test drug tablet is bioequivalent to Tagamet^® 400 mg tablet.
|
|
|
KEYWORD
|
|
|
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|