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건강한 한국인 자원자에서 테가세로드(Tegaserod) 반복 투여에 의한 안전성 및 약동학 평가
정재용,임형석,홍경섭,배균섭,유경상,조주연,이소영,고재욱,장인진,신상구,Chung, Jae-Yong,Lim, Hyeong-Seok,Hong, Kyoung-Sup,Bae, Kyun-Seop,Yu, Kyung-Sang,Cho, Joo-Youn,Yi, So-Young,Ko, Jae-Wook,Jang, In-Jin,Shin, Sang-Goo 대한임상약리학회 2003 Translational and Clinical Pharmacology Vol.11 No.2
Background: Tegaserod is a selective partial agonist at the $5HT_4$ receptor. Tegaserod belongs to a new class of agents in development for the treatment of functional motility disorders of the gastrointestinal(GD tract. This Phase I clinical study was conducted to evaluate the safety and pharmacokinetics(PK) of tegaserod in Korean for bridging foreign clinical data. Methods: A randomized, double blind, placebo controlled, multiple oral dosing(2 mg, 6 mg, twice a day for 7 days) study was conducted in 32 healthy Korean volunteers(M:F=16:16). Serial blood samples for pharmacokinetic analysis were taken. Safety evaluation was performed by adverse event monitoring, physical examination including vital signs, ECG and clinical labororatory analysis. Results: Plasma concentration of tegaserod reached peak levels $1.0{\sim}1.5$ hours after single and multiple dose administration and declined with a terminal half life of about 12 hours. PK parameters of 2 mg group were not calculated well due to low plasma concentration. Tegaserod showed linear pharmacokinetic characteristics, and little accumulation occurred after multiple administrations. There were no gender differences in PK parameters. Neither serious nor dose-limiting adverse events were observed. PK of tegaserod in Koreans was comparable to Caucasian data. Conclusion: Tegaserod was found to be safe and showed similar PK characteristics to Caucasians. This study demonstrates comparability between Korean and Caucasian healthy subjects in the PK of tegaserod and supports the use of Caucasian data in the evaluation of PK, safety, and efficacy for Korean patients.
건강 자원자에서 레베셀$^{\circledR}$주(DDB-S)의 안정성, 약동학적 특성평가를 위한 제 1상 임상시험
정재용,임형석,배균섭,유경상,홍경섭,조주연,이소영,문전옥,이치오,장인진,신상구,Chung, Jae-Yong,Lim, Hyeong-Seok,Bae, Kyun-Seop,Yu, Kyung-Sang,Hong, Kyoung-Sup,Cho, Joo-Youn,Yi, So-Young,Moon, Jun-Ok,Lee, Chi-Oh,Jang, In-Jin,Shin, Sang- 대한임상약리학회 2001 臨床藥理學會誌 Vol.9 No.2
Background : Low solubility and poor oral absorption have been major problems of DDB(Dimethyl Dime-thoxy Biphenylate), the liver protection agent. The purpose of the study was to evaluate safety, tolerablilty, and pharmacokinetics of DDB-S(Dimethoxybiphenylmonocarboxylate hydro-chloride) which was the newly developed soluble injectable form of DDB. Method : Single dose trial was conducted in 24 healthy Korean subjects with single blind, randomized, placebo controlled parallel-group design( 4 groups : 7.5, 15, 30, 60mg). DDB-S was administrated by intravenous infusion during 60 minutes. Serial blood and urine sample were collected till 24 hours after the drug administration. Plasma concentrations were assayed by HPLC. Pharmacokinetic parameters were analyzed by noncompartmental methods. Results : Total 13 cases of adverse events from 7 subjects were reported. All the events were mild, temporary, and spontaneously resolved. There were no differences in dose normalized AUC, dose normalized Cmax, CL, Vd, Tmax, Fe, $CL_R$ and elimination rate constant between groups. Linear regression analysis confirmed PK linearity within this dose range. Half of the dose$(49.86{\pm}10.97%)$ was excreted as an unchanged form through kidney. Conclusion : DDB-S was safe in Korean healthy subjects. It showed linear pharmacokinetic characteristics. Phase II clinical study for patients will be conducted.
가정용 응축식 의류건조기의 에너지 효율 개선을 위한 모델링
김정수(Jung Soo Kim),구유선(You Sun Ku),전시문(Si Moon Jeon),홍경섭(Kyung Seop Hong),임광옥(Kwang-ok Lim),이관수(Kwan-Soo Lee) 대한기계학회 2005 대한기계학회 춘추학술대회 Vol.2005 No.11
We propose a mathematical model on the characteristics of drying process and heat and mass transfer in a domestic condensing dryer to improve its energy efficiency. Experiments are also carried out to verify numerical results. We estimate temperature of the drum and the clothes separately, and perform thermal analysis of the heat exchanger using heat exchangelet method. The numerical results such as drum inlet temperature, RMC, drying time and SEC are in a good agreement with experimental data. A parameter study is also carried out to investigate the effects of each variable on dryer performance.