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양은솔,이소영,Heechan Lee,In-Jin Jang,Kyung-Sang Yu,SeungHwan Lee 대한임상약리학회 2019 Translational and Clinical Pharmacology Vol.27 No.4
Combination therapies of antihypertensive drugs are recommended in cases where hypertensionis not controlled by monotherapy. This study aimed to compare the pharmacokinetics (PKs) betweenfixed-dose combination (FDC) of fimasartan/amlodipine 60/10 mg and the correspondingloose combination. Because of the high intra-subject variability for maximum plasma concentration(Cmax) of fimasartan, a randomized, open-label, 3×3 partial replicated crossover design was adopted. Subjects received a single dose of FDC of fimasartan/amlodipine 60/10 mg or the correspondingloose combination in each period. Blood samples for PK analysis were collected up to 48 hoursfor fimasartan and 144 hours for amlodipine, respectively. Geometric mean ratios (GMRs) and its90% confidence intervals (CIs) of the FDC to the loose combination for Cmax and area under theconcentration-time curve from time 0 to the last quantifiable time point (AUClast) were calculated. Sixty healthy subjects were randomized, and 57 subjects completed the study. The concentrationtimeprofiles of fimasartan and amlodipine were similar between the FDC and loose combination. The GMRs (90% CIs) of the FDC to the loose combination for Cmax and AUClast were 1.0440(0.9202–1.1844) and 1.0412 (0.9775–1.1090) for fimasartan, and 1.0430 (1.0156–1.0711) and 1.0339(1.0055–1.0631) for amlodipine, respectively. The GMRs and its 90% CIs for Cmax and AUClast offimasartan and amlodipine were included not only in the scaled bioequivalence criteria but also inthe conventional bioequivalence criteria. In conclusion, FDC of fimasartan/amlodipine 60/10 mgshowed comparable PK profiles with the corresponding loose combination, which suggests theirbioequivalence.
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Yewon Park,WonTae Jung,양은솔,Kyu-Yeol Nam,Woo-Ri Bong,Jaehee Kim,Kyu Yeon Kim,SeungHwan Lee,Joo-Youn Cho,Jang-Hee Hong,JaeWoo Kim 대한임상약리학회 2022 Translational and Clinical Pharmacology Vol.30 No.1
UI026 is an expectorant and antitussive agent which is a new combination of Pelargonium sidoides extract and Coptis extract. The bioactive compounds of Pelargonium sidoides and Coptisextracts were identified as epicatechin and berberine, respectively. This study evaluated the effect of food on the pharmacokinetics (PKs) and safety of UI026. A randomized, openlabel, single-dose, 2-treatment, parallel study in 12 healthy male subjects was performed. Subjects received a single oral dose of UI026 (27 mL of syrup) under a fed or fasted condition according to their randomly assigned treatment. Blood samples for the PK analysis were obtained up to 24 hours post-dose for berberine and 12 hours post-dose for epicatechin. The PK parameters were calculated by non-compartmental analysis. In the fed condition, the mean maximum plasma concentration (C max ) and mean area under the plasma concentrationtime curve from time zero to the last observed time point (AUC last ) for berberine were approximately 33% and 67% lower, respectively, compared with the fasted condition, both showing statistically significant difference. For epicatechin, the mean C max and mean AUC lastwere about 29% and 45% lower, respectively, compared to the fasting condition, neither of which showed a statistically significant difference. There were no drug-related adverse events. This finding suggests that food affects the systemic exposure and bioavailability of berberine and epicatechin.
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