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김세미,강현아,조혜영,신새벽,류희두,윤화,이용복,Kim, Se-Mi,Kang, Hyun-Ah,Cho, Hea-Young,Shin, Sae-Byeok,Yoo, Hee-Doo,Yoon, Hwa,Lee, Yong-Bok 대한약학회 2008 약학회지 Vol.52 No.3
Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug 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 various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was 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 at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, 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., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.
원보 : 염산레르카니디핀 체내동태 연구를 위한 혈청 중 레르카니디핀의 LC/MS/MS 정량법 검증
김세미 ( Se Mi Kim ),김환호 ( Hwan Ho Kim ),신새벽 ( Sae Byeok Shin ),강현아 ( Hyun Ah Kang ),윤화 ( Hwa Yoon ),조혜영 ( Hea Young Cho ),김윤균 ( Yoon Gyoon Kim ),양찬우 ( Chan Woo Yang ),용철순 ( Chul Soon Yong ),이용복 ( Yong B 한국약제학회 2007 Journal of Pharmaceutical Investigation Vol.37 No.4
단보 : 솔레톤 정(잘토프로펜 80 ㎎)에 대한 삼천당잘토프로펜 정의 생물학적동등성
강현아 ( Hyun Ah Kang ),박선애 ( Sun Ae Park ),김동호 ( Dong Ho Kim ),김환호 ( Hwan Ho Kim ),윤화 ( Hwa Yun ),김경란 ( Kyung Ran Kim ),류희두 ( Hee Doo Yoo ),박은자 ( Eun Ja Park ),조혜영 ( Hea Young Cho ),이용복 ( Yong Bok Lee ) 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.3