Evaluation of pharmacokinetic drugdrug interaction between tegoprazan and clarithromycin in healthy subjects

Minkyung Oh,Heechan Lee,Seokuee Kim,Bongtae Kim,Geun Seog Song,Jae-Gook Shin,Jong-Lyul Ghim 대한임상약리학회 2023 Translational and Clinical Pharmacology Vol.31 No.2

Tegoprazan is a novel potassium-competitive acid blocker that treats gastric acid-related diseases. Clarithromycin was widely used as one of various regimens for eradicating Helicobacter pylori. This study compared the pharmacokinetic and safety profile of tegoprazan and clarithromycin between combination therapy and monotherapy to evaluate the potential drug-drug interaction. An open-label, randomized, 6-sequence, 3-period crossover study was conducted in 24 healthy subjects. According to the assigned sequence, the subject was administered the assigned treatment during 5 days in each period. PK parameters of tegoprazan and clarithromycin administered in combination were compared with those of the respective monotherapies. The co-administration of tegoprazan with clarithromycin increased maximum steady-state plasma concentration (C ss,max ) and area under the plasma concentration-time curve in dosing interval at steady-state (AUC ss,tau ) of tegoprazan (1.6-fold in C ss,max and 2.5-fold in AUC ss,tau ) and M1 (2.0-fold in C ss,max , 2.5-fold in AUC ss,tau ) than tegoprazan alone. The C ss,max and AUC ss,tau of 14-hydroxyclarithromycin increased 1.8- and 2.0-fold in co-administration, respectively. The AUC ss.tau of clarithromycin was slightly increased in co-administration, but C ss,max was not changed. Combination of tegoprazan and clarithromycin and those of the respective monotherapies were tolerated in 24 healthy subjects. There may exist drug interaction that lead to reciprocal increase in plasma drug concentrations when tegoprazan and clarithromycin were administrated in combination and no safety concerns were raised. It is suggested that an in-depth analysis of the concentrationresponse relationship is necessary to determine whether these concentration changes warrant clinical action.

Association between knee osteoarthritis and mortality: a serial propensity score-matched cohort study

Minkyung Oh,Mi-Yeong Kim,Min Wook So,Doo-Ho Lim,Su Jin Choi,Jae Ha Lee,Minyoung Her,Seong-Ho Kim,Sunggun Lee 대한내과학회 2023 The Korean Journal of Internal Medicine Vol.38 No.6

Background/Aims: The association between symptomatic knee osteoarthritis (OA) and higher cardiovascular disease (CVD) mortality is established; however, findings from studies that utilized regression analysis were limited, attributed to the strong association between OA and metabolic risk factors. This study aimed to evaluate the association between knee OA and mortality through propensity score matching. Methods: This was a cohort study including Korean National Health and Nutrition Examination Survey (2010–2013) participants aged ≥ 50 years. By linking the survey data to cause of death data (through 2019) from Statistics Korea, mortality and cause-specific mortality data were obtained. Radiographic knee OA (ROA) was defined as bilateral Kellgren–Lawrence grade ≥ 2. Propensity score matching (1:1) was conducted between asymptomatic ROA, knee pain, and symptomatic ROA groups and normal groups, balancing the confounding factors. Time to death was analyzed using Cox proportional hazard modeling. Results: A higher CVD mortality was observed in the symptomatic ROA group, but not in others; the risk estimates were asymptomatic ROA (hazard ratio [HR] 1.12; 95% confidence interval [CI] 0.77–1.65), knee pain (HR 0.61; 95% CI 0.27–1.38), and symptomatic ROA (HR 1.39; 95% CI 0.89–2.17). No association was found between the all-cause/cancer mortality and other groups. Conclusions: When propensity score matching controls metabolic risk factor imbalances, the association between symptomatic knee OA and higher CVD mortality was weaker compared to results of prior studies that used regression adjustment. The results may be more precise estimates of the total risk of knee OA for mortality in Koreans.

Pharmacokinetic and Pharmacodynamic Comparison of Two Recombinant Human Erythropoietin Formulations, PDA10 and Eprex, in Healthy Korean Male Volunteers: A Randomized, Double-Blinded, Single-Dose, Two-Period Crossover Study.

Oh, MinKyung,Yoon, Jaeseung,Cho, Doo-Yeoun Adis International 2015 Clinical drug investigation Vol.35 No.10

<P>A new biosimilar human recombinant epoetin alfa product (PDA10) has been developed by PanGen Biotech Inc., Korea. This study was planned to demonstrate the pharmacokinetic and pharmacodynamic comparability of PDA10 to an existing epoetin alfa (Eprex) after a single intravenous administration to healthy adult male volunteers.</P>

Genotype-based enrichment study design for minimizing the sample size in bioequivalence studies using tolterodine and CYP2D6 genotype

Oh, Minkyung,Yeo, Chang-Woo,Kim, Ho-Sook,Shon, Jihong,Shin, Jae-Gook Dustri-Verlag Dr. Karl Feistle 2019 International Journal of Clinical Pharmacology and Vol.57 No.2

Comparative pharmacokinetics of a fixed-dose combination vs concomitant administration of telmisartan and S-amlodipine in healthy adult volunteers

Oh, Minkyung,Park, Sung-Eun,Ghim, Jong-Lyul,Choi, Young-Kyung,Shim, Eon-Jeong,Shin, Jae-Gook,Kim, Eun-Young Dove Medical Press 2017 Drug design, development and therapy Vol.11 No.-

<P><B>Objective</B></P><P>This study compared the pharmacokinetic (PK) and safety profiles of a fixed-dose combination (FDC) formulation of telmisartan and S-amlodipine with those of concomitant administration of the two drugs.</P><P><B>Materials and methods</B></P><P>This was an open-label, randomized, crossover study in healthy male Koreans. All subjects were administered an FDC tablet containing 40 mg telmisartan and 5 mg S-amlodipine and were also coadministered the same dose of both drugs given separately. The crossover study design included a 14-day washout period between the two treatments. Blood samples were collected up to 168 h following drug administration. The plasma concentrations of telmisartan and S-amlodipine were determined by liquid chromatography tandem mass spectrometry. PK parameters and plasma concentration–time curves were compared. Safety was assessed by measuring vital signs, clinical laboratory tests, physical examinations, and patient interviews.</P><P><B>Results</B></P><P>The geometric mean ratios and 90% CIs for the maximum plasma concentration (C<SUB>max</SUB>) and area under the curve from time zero to the last sampling time (AUC<SUB>t</SUB>) were 0.8782 (0.8167–0.9444) and 0.9662 (0.9210–1.0136) for telmisartan and 1.0069 (0.9723–1.0427) and 1.0324 (0.9969–1.0690) for S-amlodipine, respectively. A total of 36 adverse events (AEs) were reported by 23 subjects, but no statistical differences were observed between the two treatments. The most frequently reported AE was a mild-to-moderate headache that was generally self-limiting.</P><P><B>Conclusion</B></P><P>For both telmisartan and S-amlodipine, the C<SUB>max</SUB> and AUC<SUB>t</SUB> 90% CIs were between ln (0.8) and ln (1.25). These results suggest that the FDC formulation is pharmacokinetically bioequivalent and has a similar safety profile to the coadministration of these drugs.</P>

Pharmacokinetic comparison of a fixed-dose combination versus concomitant administration of fimasartan, amlodipine, and rosuvastatin using partial replicated design in healthy adult subjects

Oh, Minkyung,Ghim, Jong-Lyul,Park, Sung-Eun,Kim, Eun-Young,Shin, Jae-Gook Dove Medical Press 2018 Drug design, development and therapy Vol.12 No.-

<P><B>Objective</B></P><P>The aim of this study was to compare the pharmacokinetics (PK) and safety profiles of a fixed-dose combination (FDC) formulation of fimasartan, amlodipine, and rosuvastatin with the co-administration of the two products by using a replicated crossover study design in healthy male subjects.</P><P><B>Results</B></P><P>This was an open-label, randomized, three-sequence, three-period replicated crossover study in healthy male subjects. The replicated crossover design was done because of high coefficient of variation of PK parameter for fimasartan, that is, >30%. With a 14 days washout period, an FDC tablet containing 60 mg fimasartan, 10 mg amlodipine, and 20 mg rosuvastatin was administered only once, and separate formulations of fimasartan/amlodipine 60 mg/10 mg FDC tablet and 20 mg rosuvastatin tablet administered twice. Blood samples were collected up to 72 hours following drug administration. The plasma concentrations of fimasartan, amlodipine, and rosuvastatin were measured by liquid chromatography tandem mass spectrometry. Safety was assessed by evaluating vital signs, clinical laboratory parameters, physical examinations, and medical interviews.</P><P><B>Results</B></P><P>The geometric mean ratios and 90% confidence intervals (CIs) for the maximum plasma concentration (C<SUB>max</SUB>) and area under the curve from time zero to the last measurable sampling time (AUC<SUB>t</SUB>) were 1.0776 (0.9201–1.2622) and 0.9978 (0.9538–1.0439) for fimasartan, 1.0038 (0.9782–1.0301) and 1.0055 (0.9828–1.0288) for amlodipine, and 1.0006 (0.9290–1.0776) and 0.9986 (0.9532–1.0461) for rosuvastatin, respectively. A total of 22 adverse events (AEs) were reported by 60 subjects; there were no significant differences in the incidence of AEs between the two groups.</P><P><B>Conclusion</B></P><P>The 90% CI of the C<SUB>max</SUB> of fimasartan was within the widened acceptance limit, ln(0.6984)–ln(1.4319). The 90% CIs of the other PK parameters for drugs were between ln(0.8) and ln(1.25). These results suggest that the FDC formulation is pharmacokinetically bioequivalent and has a similar safety profile, to the co-administration of its three constituent drugs.</P>

유전자 알고리즘을 이용한 Promoter 예측

오민경(Minkyung Oh),김창훈(Changhoon Kim),김기봉(Kibong Kim),공은배(EunBae Kong),김승목(SeungMok Kim) 한국정보과학회 1999 한국정보과학회 학술발표논문집 Vol.26 No.2Ⅱ

Promoter는 transcript start site 앞부분에 위치하여 RNA polymerase가 높은 친화성을 보이며 바인딩하는 DNA상의 특별한 부위로서 여기서부터 DNA transcription이 시작된다. function이나 tissue-specific gene들의그룹별로 그 promoter들의 특이한 패턴들의 조합을 발견함으로써 Specific한 transcription을 조절하는 것으로 알려져 있어 promoter로 인한 그 gene의 정보를 어느 정도 알 수가 있다. 사람의 housekeeping gene promoter들을 EPD(eukaryotic promoter database)와 EMBL nucleic acid sequence database로부터 수집하여 이것들 간에 의미 있게 나타나는 모든 패턴들을 optimization algorithm으로 알려진 genetic algorithm을 이용해서 찾아보았다.

NetFPGA 플랫폼 기반 RED스케줄러 구현 및 TCP 성능평가

오민경(Minkyung Oh),민석홍(Seokhong Min),김병철(Byungchul Kim),이재용(Jaeyong Lee) 大韓電子工學會 2012 電子工學會論文誌-TC (Telecommunications) Vol.49 No.3

최근 다양한 사용자 요구사항의 증가로 인하여 인터넷을 이용한 다양한 응용 제공에 대한 필요성이 증가하고 있다. 그러나, 단순하게 망에서 최소한의 기능만 제공하여 노드 간의 연결성만을 제공하기 위한 연구망으로 탄생한 인터넷의 근본적인 문제로 인하여 오늘날 우리가 필요로 하는 여러 가지의 다양한 응용 제공에 여러 제약들이 존재한다. 이러한 제약들은 라우팅 확장성, 이동성, 보안 및 QoS 제공 등 여러 가지 측면에서 새로운 접근을 필요로 하며, 국내외 여러 분야에서 이러한 제약들을해결하기 위한 많은 연구들이 진행되고 있다. 본 논문에서는 이러한 제약들 중 하나인 망에서의 QoS 제공에 대한 연구의 일환으로 NetFPGA 플랫폼 기반의 라우터를 이용하여 특정 확률에 따라 패킷을 폐기하는 RED(Random Early Detection) 스케줄러를 구현하고 테스트베드를 구축하였다. 이를 통해 네트워크가 혼잡하여 라우터에서 발생하는 TCP 트래픽의 패킷 손실로인한 망의 전역동기화(Global Synchronization) 현상을 방지하게 된다. 일반 라우터의 Drop Tail 방식과의 TCP 성능 비교 실험을 통하여 RED 스케쥴러가 네트워크가 혼잡한 상황에서 TCP 트래픽의 전송 성능을 향상시켜 망의 품질을 효율적으로 향상시킬 수 있음을 확인하였다. With the increase of various user's requirements, lots of interesting applications on the Internet have been emerging recently. However, Internet has many limitations for providing upcoming new services because it was only designed to provide basic connectivity between research networks and simplified forwarding functions at the first time. Internet has many problems in the aspects of routing scalability, mobility, security and QoS, so lots of researches are being actively performed in many countries to solve these problems. In this paper, we implement RED(Random Early Detection) scheduler using NetFPGA platform and local testbed to provide active queue management. Using the implemented RED scheduler, packets are dropped according to the specified drop probability, so Global Synchronization coming from simultaneous TCP segment losses in a congestion condition can be prevented. With the comparison to the Drop-Tail scheme in the basic router, we show TCP performance can be enhanced in the congestion situation sing the NetFPGA-based RED scheduler.

Measuring the Experience Economy of Film Festival Participants (pp.35-54)

Minkyung Park,Haemoon Oh,Jowon Park 한국관광학회 2010 International Journal of Tourism Sciences Vol.10 No.2

Building on Pine and Gilmore's experience economy concepts and recent related travel research, this study newly investigated the relationships among the experience of film festival visitors, their satisfaction, and their behavioral intention. In particular, the study focused on how an escapist experience and traveler satisfaction mediated the effects of the other experiential dimensions on behavioral intention. The data supported the proposed theoretical relationships among the constructs and the applicability of the experience economy scales to festival management. The results also validate a mediating role of the escapist experience between the tourist's perceptions of festival performance and behavioral intention toward future film festival participation.

유전자 알고리즘을 이용한 DNA서열상의 프로모터부위의 패턴 탐색

오민경,공은배 충남대학교 산업기술연구소 1999 산업기술연구논문집 Vol.14 No.2

A promoter is located ahead of the transcription start site in DNA sequence. In the region RNA polymerase binds with a close affinity and the transcription from DNA to RNA begins to take place from this region. RNA polymerase is an enzyme that perceives the promoter, the signal part of gene expression. The promoter is known to regulate the gene's transcription according to binding sites of transcription factors observed in promoter region in groups of function or tissue-specific genes. Therefore, we can get some information about the gene by the promoter taking charge of the gene's signal role. To identify the promoters, such as those of housekeeping genes and liver genes, we extracted the unaligned sequences up to 250bp upstream of transcription start site from EPD, EMBL nucleic acid sequence database and GenBank. We found all conserved patterns among these by genetic algorithm which is known as optimization algorithm. Patterns appearing in special groups and binding sites in TFD are similar or identical. Therefore, we think there is a close relationship between these.