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RISS 인기검색어
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- 저자 : Kim Seokuee (검색결과 4 건)
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Kim, Seokuee,Lee, Jongtae,Shin, Donghoon,Lim, Kyoung Soo,Kim, Yon Su,Jang, In-Jin,Yu, Kyung-Sang Dove Medical Press 2014 Drug design, development and therapy Vol.8 No.-
<P><B>Background</B></P><P>Fimasartan is a novel angiotensin II receptor blocker. Fimasartan is mainly eliminated via biliary excretion, and its urinary elimination is less than 3%.</P><P><B>Objective</B></P><P>Based on guidance from the United States Food and Drug Administration, a reduced pharmacokinetic (PK) study was conducted to evaluate the effect of renal function on the PK of fimasartan in patients with renal impairment and healthy volunteers.</P><P><B>Methods</B></P><P>A single centre, single-dose, open-label, healthy volunteer controlled trial was conducted in patients with renal impairment (RI) (estimated glomerular filtration rate lower than 30 mL/min/1.73 m<SUP>2</SUP>) and age-, weight- and sex-matched healthy volunteers (estimated glomerular filtration rate higher than 90 mL/min/1.73 m<SUP>2</SUP>). All participants received a single oral dose of fimasartan 120 mg, after which serial blood sampling for PK evaluation was conducted. Noncompartmental PK analysis of fimasartan was performed. A mixed-effects model approach was used to identify significant covariates and PK parameters.</P><P><B>Results</B></P><P>Sixteen subjects were enrolled (8 healthy volunteers and 8 RI patients). The maximum plasma concentrations and areas under the plasma concentration curves of the RI patients were higher than those of the healthy volunteers, with geometric mean ratios of 1.87 and 1.73, respectively. The relative bioavailability of fimasartan from the population PK analysis was 77% higher in the RI patients than in the healthy volunteers.</P><P><B>Conclusion</B></P><P>The increased drug exposure of fimasartan in RI patients was explained by the increased relative bioavailability. This result can be explained from our knowledge concerning alterations in PK related to renal function.</P>
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Han Sungpil,Choi Hee Youn,Kim Yo Han,Choi SeungChan,Kim Seokuee,Nam Ji Yeon,Kim Bongtae,Song Geun Seog,Lim Hyeong-Seok,Bae Kyun-Seop 거트앤리버 소화기연관학회협의회 2023 Gut and Liver Vol.17 No.1
Background/Aims: Tegoprazan, a novel potassium-competitive acid blocker, is expected to overcome the limitations of proton pump inhibitors and effectively control nocturnal acid breakthrough. To evaluate the pharmacodynamics of tegoprazan versus dexlansoprazole regarding nocturnal acid breakthrough in healthy subjects. Methods: In a randomized, open-label, single-dose, balanced incomplete block crossover study, 24 healthy male volunteers were enrolled and randomized to receive oral tegoprazan (50, 100, or 200 mg) or dexlansoprazole (60 mg) during each of two administration periods, separated by a 7- to 10-day washout period. Blood samples were collected for pharmacokinetic parameter analysis; gastric monitoring was performed for pharmacodynamic parameter evaluation. Results: All 24 subjects completed the study. Average maximum plasma concentration, area under the plasma concentration–time curve, and mean time with gastric pH >4 and pH >6 for tegoprazan demonstrated dose-dependent incremental increases. All the tegoprazan groups reached mean pH ≥4 within 2 hours, whereas the dexlansoprazole group required 7 hours after drug administration. Based on pharmacodynamic parameters up to 12 hours after evening dosing, 50, 100, and 200 mg of tegoprazan presented a stronger acid-suppressive effect than 60 mg of dexlansoprazole. Moreover, the dexlansoprazole group presented a comparable acid-suppressive effect with the tegoprazan groups 12 hours after dosing. Conclusions: All the tegoprazan groups demonstrated a significantly faster onset of gastric pH increase and longer holding times above pH >4 and pH >6 up to 12 hours after evening dosing than the dexlansoprazole group.
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건강한 한국인 자원자에서 바데나필 단회 투여 후 내약성 및 약동학적 특성에 관한 연구
김석의,이승환,임경수,임형석,신상구,장인진,유경상,Kim, Seokuee,Lee, SeungHwan,Lim, Kyoung Soo,Lim, Hyeong-Seok,Shin, Sang-Goo,Jang, In-Jin,Yu, Kyung-Sang 대한임상약리학회 2012 臨床藥理學會誌 Vol.20 No.2
Background: Vardenafil is a phosphodiesterase type 5 inhibitor, used in erectile dysfunction. This study aimed to evaluate the pharmacokinetics and tolerability of vardenafil following a single oral administration in healthy male subjects. Methods: A randomized, double-blind, placebo-controlled, single dosing, dose-escalation study was conducted in 30 healthy subjects. A single oral dose of vardenafil or placebo was given to 10 subjects (8 active + 2 placebo) in each dose group of 5, 10 and 20 mg. Serial blood and urine samples were obtained up to 48 hours for pharmacokinetic analysis. Vardenafil and its metabolite were detected by high performance liquid chromatography tandem mass spectrometry assay. Results: A total of 45 adverse events (AE) were reported in 22 subjects, including 5 AEs from placebo treatment, and all the AEs were mild, except one case of moderate nasal stuffiness. Vardenafil was absorbed after a single oral dose, with the $t_{max}$ of 0.5-1.0 hours. The $C_{max}$ and $AUC_{last}$ were $10.21{\pm}3.68$ ug/L($mean{\pm}SD$) and $18.08{\pm}7.44\;ug{\times}h/L$ in 5 mg dose group, $19.79{\pm}12.13$ ug/L and $38.61{\pm}21.04\;ug{\times}h/L$ in 10 mg dose group and $53.16{\pm}37.01$ ug/L and $110.05{\pm}69.65\;ug{\times}h/L$ in 20 mg dose group. Dose-linearity on $AUC_{last}$ and $C_{max}$ of vardenafil were observed in three dose groups. In all dose groups, the fraction excreted in urine was less than 1%. Conclusion: The vardenafil was tolerable over a single dose range of 5 - 20 mg. The pharmacokinetics of vardenfil after a single oral dose was explored and linear pharmacokinetic characteristics were observed over the dose range of 5 - 20 mg in healthy subjects.
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