• Title/Summary/Keyword: Crossover study

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A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration (Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험)

  • Oh, Dal-Seok;Jung, So-Young;Kim, Ae-Ran;Kang, Wee-Chang;Park, Ji-Eun;Koo, Chang-Mo;Choi, Jun-Yong;Jung, Hee-Jung;Choi, Sun-Mi;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.29 no.1
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    • pp.1-6
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    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

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Bioequivalence of Thioct Acid HR Tablet to Daewon Thioctic Acid HR Tablet 600 mg(Thioctic Acid 600 mg) (치옥타시드 에이취알 정(치옥트산 600 mg)에 대한 대원치옥트산 에이취알 정 600 mg의 생물학적 동등성)

  • Kang, Il-Mo;Lee, Heon-Woo;Lee, Hyun-Soo;Seo, Ji-Hyung;Ryu, Ju-Hee;Kim, Yong-Won;Kim, Sung-Su;Cho, Sung-Hee;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.36 no.6
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    • pp.413-419
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    • 2006
  • In this study, the main purpose was to evaluate the bioequivalence of two thioctic acid tablests, Thioctacid HR tablet(Bukwang Pharm. Co., Ltd.) and Daewon thioctic acid HR tablet 600 mg(Daewon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration(KFDA). Twenty-four, healthy Korean volunteers were divided into two groups, randomized and treated by $2{\times}2$ crossover study. After the administration of one thioctic acid tablet containing 600 mg thioctic acid, blood samples were taken until 8 hr after the oral administration. LC-MS/MS was applied to determination of thioctic acid, and we calculated the $AUC_t,\;C_{max},\;T_{max}$ from the plasma concentration-time data. Analysis of variance(ANOVA) was carried out using logarithmically transformed $AUC_t\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Daewon thioctic acid tablet 600 mg/Thioctacid HR were log 0.9877$\sim$log 1.1938 and log 0.8169$\sim$log 1.2237, respectively. These values were within the acceptable bioequivalence intervals of log 0.80$\sim$log 1.25, recommended by KFDA. In all of these results we concluded that Daewon thioctic acid tablet 600 mg was bioequivalent to Thioctacid HR tablet, in terms of rate and extent of absorption.

Bioequivalence of A-PINE Tablet to SKAD Tablet (Amlodipine Maleate 6.42 mg) (스카드 정(말레인산암로디핀 6.42 mg)에 대한 에이핀 정의 생물학적 동등성)

  • Kim, Sung-Su;Park, Wan-Su;Lee, Heon-Woo;Seo, Ji-Hyung;Kim, Yong-Won;Cho, Sung-Hee;Rew, Jae-Hwan;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.36 no.1
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    • pp.59-65
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    • 2006
  • The purpose of this study was to evaluate the bioequivalence of two amlodipine maleate tablets, SKAD tablet (SK Pharma. Co., Ltd., Seoul, Korea, reference drug) and A-PINE tablet (Daewon Pharm. Co., Ltd., Seoul, Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male volunteers, $22.79\;{\pm}\;1.86$ years in age and $70.08\;{\pm}\;8.68$ kg in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ crossover study was employed. After a tablet containing 6.42 mg of amlodipine maleate was orally administrated, blood was taken at predetermined time intervals over a period of 144 hr and concentrations of amlodipine in plasma were monitored using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$ (the area under the plasma concentration-time curve from time zero to 144 hr), $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were calculated and analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$, and untransformed $T_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for A-PINE/SKAD were $log\;0.9429{\sim}log \;1.1476$ and $log\;0.9l46{\sim}log\;1.1488$, respectively. Since these values were within the acceptable bioequivalence intervals of $log\;0.80{\sim}log\;1.25$, recommended by KFDA, it was concluded that A-PINE tablet was bioequivalent to SKAD tablet, in terms of both rate and extent of absorption.

Bioequivalence Evaluation of Two Brands of Zolpidem Tartrate 10 mg Tablets(Zanilo and Stilnox) in Healthy Male Volunteers

  • Ryu, Ju-Hee;Lee, Heon-Woo;Lee, Hyun-Su;Kang, Il-Mo;Seo, Ji-Hyung;Kang, Jin-Yang;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.36 no.5
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    • pp.343-348
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    • 2006
  • The purpose of the present study was to evaluate the bioequivalence of two zolpidem tartrate tablets, Stilnox tablet(Sanofi-aventis Korea, reference product) and Zanilo tablet(ChoDang Pharm Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration(KFDA). After adding an internal standard(cimetropium), 250 ${\mu}L$ plasma samples were extracted using 1.3 mL of ethyl acetate. Extracted compounds were analyzed by HPLC with triple-quadrupole mass spectrometry. This method for determination of zolpidem is proved accurate and reproducible with the limit of quantitation of 1 ng/mL in human plasma. Twenty-four healthy male Korean volunteers received each medicine at the zolpidem tartrate dose of 10 mg in a $2{\times}2$ crossover study. There was one-week washout period between the doses. Plasma concentrations of zolpidem were monitored for over a period of 8 hr after the administration. $AUC_{0-t}$(the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{0-t}$ and $C_{max}$. No significant sequence effect was found for all of the bio-availability parameters indicating that the crossover design was properly performed. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25(e.g., log 0.92-log 1.06 for $AUC_{0-t}$, log 0.96-log 1.13 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zanilo tablet is bioequivalent to Stilnox tablet.

Bioequivalence of Atorva Tablet® to Lipitor Tablet® (Atorvastatin 20 mg) (리피토정® (아토르바스타틴 20 mg)에 대한 아토르바정®의 생물학적동등성)

  • Lim, Hyun-Kyun;Lee, Tae-Ho;Lee, Jae-Hyun;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang-Beom
    • Journal of Pharmaceutical Investigation
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    • v.38 no.2
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    • pp.135-142
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    • 2008
  • The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

Development of evolutionary algorithm for determining the k most vital arcs in shortest path problem

  • Chung, Hoyeon;Shin, Dongju
    • Proceedings of the Korean Operations and Management Science Society Conference
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    • 2000.10a
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    • pp.113-116
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    • 2000
  • The purpose of this study is to present a method for determining the k most vital arcs in shortest path problem using an evolutionary algorithm. The problem of finding the k most vital arcs in shortest path problem is to find a set of k arcs whose simultaneous removal from the network causes the greatest increase in the total length of shortest path. The problem determining the k most vital arcs in shortest path problem has known as NP-hard. Therefore, in order to deal with the problem of real world the heuristic algorithm is needed. In this study we propose to the method of finding the k-MVA in shortest path problem using an evolutionary algorithm which known as the most efficient algorithm among heuristics. For this, the expression method of individuals compatible with the characteristics of shortest path problem, the parameter values of constitution gene, size of the initial population, crossover rate and mutation rate etc. are specified and then the effective genetic algorithm will be proposed. The method presented in this study is developed using the library of the evolutionary algorithm framework (EAF) and then the performance of algorithm is analyzed through the computer experiment.

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Effects of SM-2015 on Blood Alcohol Clearance and Hangover (SM-2015의 혈중 알코올 분해 및 숙취 개선 효과)

  • Shin, Seon-mi;Park, Sun-young;Kim, Tae-yeon
    • The Journal of Internal Korean Medicine
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    • v.38 no.1
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    • pp.20-31
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    • 2017
  • Objectives: This study investigated the effect of SM-2015 on blood alcohol clearance and hangover. We undertook this study to test whether SM-2015 is effective in decreasing blood alcohol concentration and preventing the symptoms of alcohol-induced hangover. Methods: Twenty healthy volunteers participated in this randomized crossover study. All participants were classified between an SM-2015 intake group (test group) and a non-intake group (control group). The primary outcome measure was the difference in blood alcohol concentration and hangover severity scores between the test and control groups. The secondary outcome measure was the difference in a liver function test (LFT) between the test and control groups. Results: After alcohol exposure, the sensitivity scores of blood alcohol concentration and hangover symptoms (sleepiness, dizziness, nausea, weakness, stomach pain, diarrhea, and concentration disorder) were significantly decreased in the SM-2015 intake group compared with the non-intake group. There were no differences in the LFT results between the SM-2015 intake group and the non-intake group. Conclusions: SM-2015 is effective in decreasing blood alcohol concentration and preventing the symptoms of alcohol-induced hangover. Larger studies are required to confirm these findings.

Historical Review of Korean Traditional Baeja, and an Exploration of its Modernization (한국 전통 배자의 복식사적 고찰과 현대화 작업)

  • Lee, Eun-Hyung;Cho, Hyo-Sook
    • Journal of the Korean Society of Costume
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    • v.59 no.9
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    • pp.115-130
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    • 2009
  • A kind of Korean traditional jacket, Baeja, has been a Korean traditional costume equipped with practicality and formative aesthetics from the Three Kingdoms period to the Joseon Dynasty. Accordingly, the researcher of this study highly valued a modern sense of Baeja with various types of design and forms and attempted to make efforts to apply it into modern life. This study provided a new direction in the modernization work of traditional costumes by creating fashion images newly interpreted corresponding to a modern sense and trend through the application of formative characteristics and noticeable elements via the coordination of traditional Baeja and modern costumes. On the one hand, it would be meaningful in terms of contributing to the activation of traditional Hanbok by providing people with ample opportunities to wear it in modern daily lives variously. On the other hand, the actual purpose of this study was to perform a modernization work for traditional costumes by attempting to conduct a crossover that could let people move into other areas freely, that is, a creative and innovative research associating the area of costume history and that of coordination.

Involvement of Selective Alpha-2 Adrenoreceptor in Sympathetically Maintained Pain

  • Park, Chan-Hong;Yong, An;Lee, Sang-Ho
    • Journal of Korean Neurosurgical Society
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    • v.47 no.6
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    • pp.420-423
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    • 2010
  • Objective : Peripheral nerve injury often leads to neuropathic pain, which is characterized by burning pain, allodynia, and hyperalgesia. The role of the sympathetic nervous system in neuropathic pain is a complex and controversial issue. It is generally accepted that the alpha adrenoreceptor (AR) in sympathetic nerve system plays a significant role in the maintenance of pain. Among alpha adrenoreceptor, alpha-1 receptors play a major role in the sympathetic mediated pain. The primary goal of this study is to test the hypothesis that sympathetically maintained pain involves peripheral alpha-2 receptors in human. Methods : The study was a randomized, prospective, double-blinded, crossover study involving twenty patients. The treatments were : Yohimbine (30 mg mixed in 500 mL normal saline), and Phentolamine (1 mg/kg in 500 mL normal saline) in 500 mL normal saline at 70 mL/hr initially then titrated. The patients underwent infusions on three different appointments, at least one month apart. Thus, all patients received all 2 treatments. Pain measurement was by visual analogue scale, neuropathic pain questionnaire, and McGill pain questionnaire. Results : There were significant decreases in the visual analogue scale, neuropathic score, McGill pain score of yohimnine, and phentolamine. Conclusion : We conclude that alpha-2 adrenoreceptor, along with alpha-2 adrenoreceptor, may be play role in sympathetically maintained pain in human.

A Clinical Study on the Effect of Crossing over Treatment of Acupuncture and Herbal Medication for Primary Dysmenorrhea (침(鍼)-한약(韓藥)의 교차(交叉) 치료(治療)가 원발성(原發性) 월경통(月經痛)에 미치는 효과(效果)에 대한 연구(硏究))

  • Lim, Eun-Mee;Yuk, Sang-Suk
    • The Journal of Korean Obstetrics and Gynecology
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    • v.18 no.4
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    • pp.144-152
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    • 2005
  • Purpose : The purpose of this study is to identify the clinical effects of acupuncture and herbal medication in the treatment of primary dysmenorrhea during five or seven days before menstruation. Methods : This study was carried out to the 17 female students in kyungwon university without pelvic or other systemic disease and its history. We investigated general and menstrual characteristics through questionnaires and treated sample patients with crossover acupuncture treatment(Sojangjeonggyeok & $SP_6$) and herbal medication(Hyunburikyungtang-gagam) during five or seven days before menstruation two times. And the change of pain was measured by the method of VAS after menstration monthly two times. Results : The improvement frequency of pain after treatment according to VAS all got better after one, two months of treatment. Especially, the mean${\pm}$S.E. of VAS score after 2nd month treatment was decreased significantly compared with that of 1st month treatment(p<0.05). And Between acupuncture treatment and herbal medication groups had no significant differences on the efficacy of treatment. Conclusion : The acupuncture treatment or herbal medication during five or seven days before menstruation will be efficacious against primary dysmenorrhea.

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