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액시드 캅셀(니자티딘 150 mg)에 대한 넥스 캅셀의 생물학적 동등성
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  • 액시드 캅셀(니자티딘 150 mg)에 대한 넥스 캅셀의 생물학적 동등성
저자명
김지만,이상봉,전성실,신영희,Kim. Ji-Man,Lee. Sang-Bong,Jeon. Seong-Sill,Shin. Young-Hee
간행물명
藥劑學會誌
권/호정보
2004년|34권 1호|pp.43-48 (6 pages)
발행정보
한국약제학회
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정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

The purpose of the present study was to evaluate the bioequivalence of two nizatidine capsules, Axid (Lilly Korea Pharm. Co., Ltd.) and Nex (Bi-nex Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The nizatidine release from the two nizatidine capsules in vitro was tested using KP Apparatus method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). The dissolution prefers of two nizatidine capsules were very similar at all dissolution media. Twenty four normal male volunteers were divided into two groups with a randomized 22 crossover study. After two capsules (300 mg nizatidine) were orally administrated, blood was taken and the concentrations of nizatidine in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were determined. The result showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two nizatidine capsules based on the Axid were -6.16%, -8.26% and -1.82%, respectively. There were no sequence effects between two capsules in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(125)(e.g., $log(0.91){sim}log(0.97)$ and $log(0.85) {sim}log(0.99)$ for $AUC_t$ and $C_{max}$ respectively), indicting that Nex capsule is bioequivalent to Axid capsule.