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모빅 캡슐(멜록시캄 7.5 mg)에 대한 멜락스 캡슐의 생물학적동등성
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  • 모빅 캡슐(멜록시캄 7.5 mg)에 대한 멜락스 캡슐의 생물학적동등성
저자명
이예리,염승복,고연정,고정길,김호현,이희주,이경률,Lee. Ye-Rie,Yeom. Seung-Bock,Ko. Youn-Jung,Ko. Jung-Kil,Kim. Ho-Hyun,Lee. Hee-Joo,Lee. Kyung-Ryul
간행물명
藥劑學會誌
권/호정보
2004년|34권 5호|pp.413-418 (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

A bioequivalence of $Melax^{TM}$ capsules (Chong Kun Dang Pharm., Korea) and $Mobic^{TM}$ capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15 mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2;{ imes};2$ crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 72 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Melax^{TM}/Mobic^{TM}$ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of $Melax^{TM}$ and $Mobic^{TM}$ with respect to the rate and extent of absorption.