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건일로딘 정(미결정에토돌락 200 ㎎)에 대한 에토돌 정의 생물학적동등성
이정애,이윤영,조태섭,박영준,문병석,김호현,이예리,이희주,이경률 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.4
A bioequivalence of Etodol™ tablets (Yuhan corporation) and Kuhnillodine™ tablets (Kuhnil Pharm, Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 ㎎ dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a 2×2 cross-over design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. AUCt (the area under the plasma concentration-time curve from time zero to 24 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 AUCt 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 Etodol™/Kuhnillodine™ were 1.01 - 1.10 and 0.87 - 1.06, respectively. This study demonstrated a bioequivalence of Etodol™ and Kuhnillodine™ with respect to the rate and extent of absorption.
루리드 정(록시스로마이신 150㎎)에 대한 록시스린 정의 생물학적동등성
정선경,이윤영,조태섭,김호현,이예리,이경률,이희주 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.3
A bioequivalence study of Roxithrin™ tablet (Kukje Pharma. Ind. Co., Ltd.) to Rulid™ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a 2×2 crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. AUC, (the area under the plasma concentration-time curve from time zero to 36 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 carried out using logarithmically transformed AUC, and C_(max). No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the AUC, ratio and the C_(max) ratio for Roxithrin™/Rulid™ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of Roxithrin™ and Rulid™ with respect to the rate and extent of absorption.
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.
박석,이예리,김호현,이희주,김윤균,염정록,한상범 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.6
A sensitive method for quantification of pinaverium bromide in human plasma was established using liquid chromatography-electrospray ionization tandem mass spectrometrv(LC-ESI-MS/MS). Glimepiride was used as internal standard. Pinaverium bromide and internal standard in plasma sample were extracted using tert-but}lmethvlether(TBME). A centrifuged upper laver was then evaporated and reconstituted with mobile phase of acetonitrile-5 m1VI ammonium formate (8020. pH 3.0). The reconstituted samples were injected into a C_(18) reversed-phase column. Using MS/MS with multiple reaction monitoring (MRM) mode. pinaverium and glimepirde were detected without severe interference from human plasma matrix. Pinaverium produced a protonated precursor ion ([M+H]^(+)) at m/z 510.3 and a corresponding product ion at m/z 228.9. Internal standard produced a protonated precursor ion ([M+H] ^(+)) at m/z 491.5 and a corresponding product ion at m/z 352.0. Detection of pinaverium bromide in human plasma was accurate and precise. with limit of quantitation at 0.5 ng/ml. The method has been successfully applied to bioavailability study of pinaverium bromide tablet in Korean healthy male volunteers. Pharmacokinetic parameters such as AUCr. C_(max) T_(max). K_(el) and t_(l/2) were calculated.
동아가스터 정(파모티딘 20㎎)에 대한 베스티딘 정의 생물학적동등성
박창훈,정선경,최미희,김호현,이예리,이희주,이경률 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.6
A bioequivalence study of Bestidine™ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A Gaster™ (Dong-A Pharmaceutical Co.. Ltd.. Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a 2x2 crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. AUCr (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. Cma, (maximum plasma drug concentration) and Tma, (time to reach Cma,) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCr and Cma,. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the AUCr ratio and the Cmax ratio for Bestidine™/ Gaster™ were log 0.90-log 1.06 and log 0.98-log 1.20. respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of Bestidine™ and Gaster™ with respect to the rate and extent of absorption.