가바펜틴 800밀리그람 정제의 생물학적동등성시험

• 영문명: Bioequivalence Test of Gabapentin 800 mg Tablets
• 발행기관: 대한약학회
• 저자명: 김세미(Se-Mi Kim) 신새벽(Sae-Byeok Shin) 강현아(Hyun-Ah Kang) 조혜영(Hea-Young Cho) 이용복(Yong-Bok Lee)
• 간행물 정보: 『약학회지』제52권 제4호 (2008년), 299~305쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2008.08.31

영문 초록

Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, Neurontin？？ tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCl dissolution media. Twenty six healthy male subjects, 23.85±2.24 years in age and 69.40±11.11 kg in body weight, were divided into two groups and a randomized 2×2 crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. 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, Neurontin？？, were 1.28%, 0.63% and 0.62% 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., log0.9097~log1.1598 and log0.8919~log1.1262 for AUCt and Cmax, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to Neurontin？？ tablet 800 mg.

키워드

Gabapentin Neurontin？？ tablet Gabapenin tablet Bioequivalence HPLC