건강한 자원자에서 JES9501 단회 및 반복 경구투여 후안전성 및 약동 · 약력학적 특성에 관한 연구

김언혜,김보형,신동성,조주연,유경상,장인진,정재용 대한임상약리학회 2013 Translational and Clinical Pharmacology Vol.21 No.2

Background: JES9501 is dehydroevodiamine, the extract of Evodia rutaecarpa, expected to be a new therapeutic for Alzheimer disease. This study aims to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of JES9501 after single or multiple dosing. Methods: A double-blind, randomized, placebo-controlled, dose ascending, parallel study was conducted in healthy subjects. A single dose of JES9501 50․100․200․400 or 800 mg and multiple doses of JES9501 100․200 or 400 mg once-daily for 7days was administered. Serial blood and urine samples for PK evaluation were collected. Acetylcholinesterase (AChE) activity was measured for PD evaluation in multiple dose group. Results: In the single dose study, means of dose-normalized peak concentration (Cmax) of 100․200․400 and 800 mg dose group are comparable except 50 mg dose group. Means of dose-normalized area under the plasma concentration-time curve (AUC) from dosing to the last quantifiable concentration of corresponding dose group were similar. At steady state in the multiple dose study, means of dose-normalized Cmax and AUC for dosing interval of 100․200 and 400 mg dose group decreased as the dose increased, however those were not relevant. There was no significant difference of AChE activity between three dosage groups and placebo group. Adverse events related to study drug were all mild and there were no remarkable findings. Conclusion: JES9501 was safe and well-tolerated after single or multiple doses in healthy male subjects. Further studies are warranted to evaluate the PK of optimized dosage form and to prove the drug effect in clinical trials for Alzheimer disease patients.

다국적 기업의 현지화 광고 제작 과정에서 나타난 체육계 전문가의 문화 매개 경험

김언혜,장익영,이원미,박슬기,송민규 한국문화융합학회 2022 문화와 융합 Vol.44 No.11

The purpose of this study is to examine how Nike, the main body of global media, and the autonomy of local Sports Professionals in the production of glocalized advertisements for multinational companies, are balanced, and to explore the role and limitations of sports workers as cultural intermediaries. The study's findings are listed below. First, the study participants participated in the production of glocalization advertisements for Nike, a multinational corporation, from an outsider called a sports expert to an insider called a cultural intermediaries. Second, Participants in the study were found to carry out cultural mediation activities such as changing sports, simplifying physical activities, and sharing data to actively reproduce the sports culture as cultural intermediaries, and trying to project the essence of sports into glocalization advertisements. They also attempted to project the essence of sports into glocalization advertisements. Third, it was noted that study participants felt left out from cultural mediation activities because of their ability to participate as cultural intermediaries was limited by multinational corporations.

대학운동부의 인권감수성

김언혜(Eon-Hye Kim),장익영(Ik-Young Chang) 한국엔터테인먼트산업학회 2020 한국엔터테인먼트산업학회논문지 Vol.14 No.8

이 연구는 대학운동부를 대상으로 인권감수성 수준을 알아보고 변인 간 인권감수성의 차이를 비교·분석하는 데 목적이 있다. 이러한 연구의 목적을 달성하기 위해 한국대학스포츠협의회에 등록된 대학을 중심으로 10개 대학교의 운동선수 188명을 유층집락 무선표집으로 설문조사하였다. 수집된 자료는 IBM SP SS 24.0 프로그램을 사용하여 빈도분석을 실시하였고, 신뢰도를 구하기 위하여 cronbach’s α를 산출하였다. 대학운동부의 다양한 특성에 따라 인권감수성 수준의 차이를 검증하기 위해서 기술통계분석, one-way ANOVA, 사후검증 방법으로 Scheffe를 사용하였으며, 다음과 같은 결론을 도출하였다. 첫째, 에피소드 중 대학운동부의 인권감수성 점수가 가장 높게 나타난 에피소드는 이주노동자의 노동권과 노인의 행복권이며, 인권감수성 점수가 가장 낮게 나타난 에피소드는 구금으로부터의 자유권, 사생활권이다. 또한, 인권감수성의 하위요인 중 책임지각과 상황지각이 결과지각보다 높다. 둘째, 대학운동부 특성에 따른 대학운동부의 인권감수성은 학교운동부규모, 수상실적에 따라 유의한 차이가 있다. 셋째, 대학운동부의 교육특성에 따른 대학운동부의 인권감수성 수준은 유의한 차이가 있다. This study aims to understand human rights sensibility in university varsity teams and to compare and analyze differences in human rights sensibility by variables related to university varsity teams. In order to achieve the purpose of this study, 188 student-athletes from 10 universities were selected. The collected data were analyzed in descriptive analysis, reliability analysis, one-way ANOVA, Scheffe using IBM SPSS 24.0. First, based on the episodes, the episodes with the highest human rights sensitivity are the right to labor of migrant workers and happiness rights, and the episodes with the lowest human rights sensitivity are the right to freedom of detention and privacy rights. In addition, among the sub-factors of human rights sensitivity, perception of responsibility and perception of behavior are higher than perception of outcome. Second, there are differences in the human rights sensitivity of the university varsity team depending on the size and the level of performance of the university varsity team. Third, there are differences in the human rights sensibility of the university varsity team depending on the educational characteristics (volunteer activity and human rights education) of the university varsity team.

Pharmacokinetics and bioequivalence of two different 20 mg olmesartan tablets: A randomized, single-dose, two-period crossover study in healthy Korean male volunteers

이지언,김언혜,유경상,정재용,임성빈,김보형 대한임상약리학회 2016 Translational and Clinical Pharmacology Vol.24 No.2

Olmesartan is an angiotensin receptor blocker (ARB) and is widely used in clinical practice to treat hypertension. To compare the pharmacokinetic (PK) parameters and tolerability of two oral for¬mulations of olmesartan (test drug: OMETAN® 20 mg tablet, reference drug: OLMETEC® 20 mg tablet) and assess their bioequivalence, a randomized, single dose, two-treatment crossover clinical study was conducted. At each period, 40 subjects received the test drug or the reference drug. Blood samples were collected at pre-dose and up to 48 h after study drug administration of each period. Plasma concentrations of olmesartan were measured using liquid chromatography-tandem mass spectrometry. To evaluate PK profiles, maximum plasma concentration (Cmax) and area under the concentration-time curve from zero to last measurable time (AUClast) were estimated using a non-compartmental method. Tolerability was evaluated based on the incidence of adverse events, vital signs, electrocardiograms, and laboratory tests. A total of 39 subjects completed the study. The geometric mean ratio and 90% confidence intervals (CI) of test drug to reference drug were 1.027 (0.969–1.088) for Cmax and 1.014 (0.957–1.074) for AUClast, respectively. There were no serious ad¬verse events and both formulations of olmesartan were well tolerated. The OMETAN 20 mg tablet was judged to be bioequivalent to the OLMETEC 20 mg tablet. Olmesartan is an angiotensin receptor blocker (ARB) and is widely used in clinical practice to treat hypertension. To compare the pharmacokinetic (PK) parameters and tolerability of two oral formulations of olmesartan (test drug: OMETAN® 20 mg tablet, reference drug: OLMETEC® 20 mg tablet) and assess their bioequivalence, a randomized, single dose, two-treatment crossover clinical study was conducted. At each period, 40 subjects received the test drug or the reference drug. Blood samples were collected at pre-dose and up to 48 h after study drug administration of each period. Plasma concentrations of olmesartan were measured using liquid chromatography-tandem mass spectrometry. To evaluate PK profiles, maximum plasma concentration (Cmax) and area under the concentration-time curve from zero to last measurable time (AUClast) were estimated using a non-compartmental method. Tolerability was evaluated based on the incidence of adverse events, vital signs, electrocardiograms, and laboratory tests. A total of 39 subjects completed the study. The geometric mean ratio and 90% confidence intervals (CI) of test drug to reference drug were 1.027 (0.969-1.088) for Cmax and 1.014 (0.957-1.074) for AUClast, respectively. There were no serious adverse events and both formulations of olmesartan were well tolerated. The OMETAN 20 mg tablet was judged to be bioequivalent to the OLMETEC 20 mg tablet.

Pharmacokinetics and bioequivalence of two different 20 mg olmesartan tablets: A randomized, single-dose, two-period crossover study in healthy Korean male volunteers

Jieon Lee,김언혜,유경상,정재용,임성빈,김보형 대한임상약리학회 2015 Translational and Clinical Pharmacology Vol.23 No.2

Olmesartan is an angiotensin receptor blocker (ARB) and is widely used in clinical practice to treathypertension. To compare the pharmacokinetic (PK) parameters and tolerability of two oral formulationsof olmesartan (test drug: OMETAN® 20 mg tablet, reference drug: OLMETEC® 20 mgtablet) and assess their bioequivalence, a randomized, single dose, two-treatment crossover clinicalstudy was conducted. At each period, 40 subjects received the test drug or the reference drug. Bloodsamples were collected at pre-dose and up to 48 h after study drug administration of each period. Plasma concentrations of olmesartan were measured using liquid chromatography-tandem massspectrometry. To evaluate PK profiles, maximum plasma concentration (Cmax) and area under theconcentration-time curve from zero to last measurable time (AUClast) were estimated using a noncompartmentalmethod. Tolerability was evaluated based on the incidence of adverse events, vitalsigns, electrocardiograms, and laboratory tests. A total of 39 subjects completed the study. Thegeometric mean ratio and 90% confidence intervals (CI) of test drug to reference drug were 1.027(0.969–1.088) for Cmax and 1.014 (0.957–1.074) for AUClast, respectively. There were no serious adverseevents and both formulations of olmesartan were well tolerated. The OMETAN 20 mg tabletwas judged to be bioequivalent to the OLMETEC 20 mg tablet

Increasing Prevalence and Mortality of Asthma With Age in Korea, 2002–2015: A Nationwide, Population-Based Study

Eun-young Lee,김언혜,Young Min Ye,Sang-Eun Choi,박해심 대한천식알레르기학회 2020 Allergy, Asthma & Immunology Research Vol.12 No.3

Purpose: The prevalence of asthma is increasing globally as the world population increases; however, and the prevalence and mortality of asthma have not been extensively investigated. Also, the effects of severity and aging on asthma prevalence and mortality are unknown. We aimed to investigate trends of the prevalence and mortality of asthma as well as health care uses and costs over 14 years according to disease severity by using real-world data in Korea. Methods: Using the National Health Insurance Sharing Service database, we extracted asthmatic patients having diagnosis codes of asthma and prescription records of antiasthmatic medications from 2002 to 2015 and categorized them according to asthma exacerbation and regular treatment. We defined asthma-associated death in terms of patients' prescription records within 3 months before all-cause death, then linked with the Cause of Death Statistics. The annual asthma-related health care uses and costs were analyzed. Results: The prevalence rates of asthma (1.6% to 2.2%) and severe asthma (SA; 3.5% to 6.1% among total asthmatics) have increased steadily over the decade in Korea, where the proportion of elderly asthmatics having increased. The asthma-related health care uses and costs had increased during the study period with the highest uses/costs in SA. The asthma mortality had a steady rising trend from 16.2 to 28.0 deaths per 100,000 with the highest mortality in SA. Conclusions: The prevalence and mortality of asthma as well as SA increases along with the burden of health care uses/costs. More active interventions, including changes in health care policies, are needed to reduce the prevalence and mortality of asthma, especially SA.

Comparison of international guidelines for early-phase clinical trials of cellular and gene therapy products

Wonsuk Shin,Min-Gul Kim,김언혜 대한임상약리학회 2022 Translational and Clinical Pharmacology Vol.30 No.1

Cellular and gene therapies (CGT) are promising fields that are bringing significant clinical benefits to patients by directly targeting the underlying cause of disease. In line with this trend, regulatory agencies in every country have been making efforts to accelerate CGT product development. For acceleration, it is necessary to increase the efficiency of clinical trials, thus the early-phase clinical trials for CGT products should be elaborate and productive. The guidelines of international regulatory agencies were compared and analyzed to examine the considerations for the design of early-phase CGT products. The guidelines described a safety evaluation, preliminary evidence of effectiveness gathering, dose exploration, and a feasibility assessment as common objectives of early-phase clinical trials for CGT products. In addition, the considerations for the design of early-phase CGT products included pretreatment effects and problems in the manufacturing and administration process. The guidelines also covered selection of a study population, control group/blinding, and dose/regimen planning. There were differences in the degree of detail, description, and the scope of the content covered by each guideline. The guideline published by FDA was the most specific. However, when compared with the previous guidelines for designing earlyphase clinical trials for small molecules and biologics, the current guidelines need to be revised to suggest more detailed and practical principles and rules.

Bioequivalence of the pharmacokinetics between tofacitinib aspartate and tofacitinib citrate in healthy subjects

신원석,A-Young Yang,Hyeonji Yun,조두연,Kyung Hee Park,Hyunju Shin,김언혜 대한임상약리학회 2020 Translational and Clinical Pharmacology Vol.28 No.3

Tofacitinib is an oral disease-modifying anti-rheumatic drug to selectively inhibit Janus kinases. Tofacitinib is a representative small molecule inhibitor that is used to treat many diseases including rheumatoid arthritis and various autoimmune conditions. Unlike biological agents, tofacitinib has several advantages, including the ability to be administered orally and a short half-life. This study aimed to evaluate the bioequivalence of the pharmacokinetics (PK) between tofacitinib aspartate 7.13 mg (test formulation) and tofacitinib citrate 8.08 mg (reference formulation; Xeljanz®) in healthy subjects. A randomized, open-label, single-dose, 2-sequence, 2-period, 2-treatment crossover trial was conducted in 41 healthy volunteers. A total of 5 mg of tofacitinib as the test or the reference formulation was administered, and serial blood samples were collected up to 14 hours after dosing for PK analyses. The plasma concentration of tofacitinib was determined by ultraperformance liquid chromatography-tandem mass spectrometry. A non-compartmental analysis was used to estimate the PK parameters. A total of 35 subjects completed the study and the study drug was well-tolerated. The mean maximum concentration (Cmax) and area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for the test formulation were 52.67 ng/mL and 133.86 ng∙h/mL, respectively, and 50.61 ng/mL and 133.49 h∙ng/mL for the reference formulation, respectively. The geometric mean ratios (90% confidence intervals) of the Cmax and AUClast between the 2 formulations were 1.041 (0.944–1.148) and 1.003 (0.968–1.039), respectively. Tofacitinib aspartate exhibited bioequivalent PK profiles to those of the reference formulation.