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모빅 캡슐(멜록시캄 7.5㎎)에 대한 멜락스 캡슐의 생물학적동등성
이예리,염승복,고연정,고정길,김호현,이희주,이경률 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
A bioequivalence of Melax capsules (Chong Kun Dang Pharm., Korea) and Mobic™ 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 x 2 crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. AUC, (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 Cma,.) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed AUC, and C_(max). No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the AUCt ratio and the C_(max) ratio for Melax™/Mobic™ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of Melax™ and Mobic™ with respect to the rate and extent of absorption.
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모빅 캡슐(멜록시캄 7.5mg)에 대한 멜락스 캡슐의 생물학적동등성
이희주,이예리,염승복,고연정,고정길,김호현,이경률 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5
A bioequivalence of MelaxTM capsules (Chong Kun Dang Pharm., Korea) and MobicTM capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a 2´2 crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. AUCt (the area under the plasma concentration-time curve from time zero to 72hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed AUCt and Cmax. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for MelaxTM/MobicTM were 0.95-1.04 and 0.98-1.14, respectively. This study demonstrated a bioequivalence of MelaxTM and MobicTM with respect to the rate and extent of absorption.
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