• 제목/요약/키워드: Fasting state

검색결과 133건 처리시간 0.026초

세파클러 375 mg서방정의 생물학적 동등성 (Bioequivalence of Cefaclor 375 mg SR Tablet)

  • 이신화;윤민혁;최경업;권광일
    • 한국임상약학회지
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    • 제13권1호
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    • pp.13-17
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    • 2003
  • This study was carried out to compare the bioavailability of $Ceclex^{(R)}$ SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor $MR^{(R)}$ SR IAB (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean volunteers. The bioavailability was examined on 24 healthy volunteers who received a single dose (375 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 7 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters $(AUC_{0-7h},\;C_{max},\;T_{max},\;AUC_{inf},\;K_e,\;t_{1/2},\;V_d/F,\;and\;CL/F)$ were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the $T_{max}$, log-transformed $AUC_{0-7h$}$, log-transformed $C_{max},\;t_{1/2},\;V_d/F$, and $CL/F$. The ratios of geometric means of $AUC_{0-7h}\;and\;C_{max}$ between test drug End reference drug were $95.67\%\;(8.55\;vs\;8.18{\mu}g{\cdot}hr/ml)\;and\;103.86\%\;(2.85\;vs\;2.96{\mu}g/ml)$, respectively. The $T_{max}$ of test drug and reference drug was $2.56\pm0.15\;and\;2.23\pm0.13\;hrs,\;respectively.\;The\;90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-7h}\;and\;C_{max}$ were log0.90-log1.04 and log0.91-log1.13, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug.

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LC/MS/MS를 이용한 가바펜틴 300 mg 캡슐의 성인 지원자에 대한 생물학적 동등성 및 약물동태 연구 (Bioequivalence and Pharmacokinetic study of Gabapentin 300mg Capsules using Liquid Chromatography-Tandem Mass Spectrometry (LC/MS/MS) in Volunteers)

  • 정지훈;권준택;윤휘열;강원구;권광일
    • 한국임상약학회지
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    • 제16권1호
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    • pp.63-68
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    • 2006
  • Gabapentin, 1-(aminomethyl-1-cyclohexyl)acetic acid, is anew antiepileptic drug related to ${\gamma}-aminobutyric$ acid(GABA) currently being introduced in therapy worldwide. The bioavailability and pharmacokinetics of gabapentin capsules were examined in 22 volunteers who received a single oral dose in the fasting state by randomized balanced $2{\times}2$ crossover design. After dosing, blood samples were collected for a period of 24 hours and analyzed by liquid chromatography-tandem mass spectrometry (LC/MS/MS). Time course of plasma gabapentin concentration was analyzed with non-compartmental and compartmental approaches. $WinNonlin^{(R)}$, the kinetic computer program, was used for compartmental analysis. One compartment model with first-order input, first-order output with no lag time and weighting by $1/(predieted\;y)^2$ was chosen as the most appropriate pharmacokinetic model for the volunteers. The major pharmacokinetic parameters $(AUC_{0-24hr},\;AUC_{inf},\;C_{max}\;and\;T_{max})$ and other parameters $(K_a,\;K_{el},\;V_d/F\;and\;Cl/F)$ of $Gapentin^{TM}$ (test drug) and $Neurontin^{TM}$ (reference drug) were estimated by non-compartmental analysis and compartmental analysis. The 90% confidence intervals of mean difference of logarithmic transformed $AUC_{0-24hr}\;and\;C_{max}$ were $log(0.9106){\sim}log(1.l254)\;and\;log(0.8521){\sim}log(1.0505)$, respectively. It shows that the bioavailability of the test drug is equivalent with that of the reference drug. There was no statistically significant difference between the two drugs in all pharmacokinetic parameters.

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깨죽이 정상 성인의 혈장 Gastrin 농도에 미치는 영향 (Plasma Gastrin Concentraion after Ingestion of Sesame Gruel in Normal Human Subjects)

  • 김명석;이윤렬;권경옥;조양혁;박형진
    • The Korean Journal of Physiology
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    • 제16권2호
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    • pp.209-213
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    • 1982
  • This study was conducted to investigate the effect of ingestion of sesame (Sesamum indicum) gruel as a nourishing meal upon the plasma gastrin concentration in normal Korean. Sixteen normal persons with no history of gastrointestinal diseases, including male and female were studied. After an overnight(about 15 hrs) fast, eight persons(mean age: 26.6, range: $20{\sim}40$ years) of them ingested a 350 ml sesame gruel corresponding to 12 g protein, 13 g fat and 99 g carbohydrate, and the remaining 8 subjects(mean age: 21.3, range: $20{\sim}24$ years) ingested a 350 ml glutinous rice gruel(control meal) corresponding to 8 g protein, 1 g fat and 115 g carbohydrate. The venous blood samples were drawn before and after the ingestion of the test meal for the measurement of gastrin by means of radioimmunoassay. 1) Plasma gastrin concentration in response to the ingestion of sesame gruel or glutinous rice gruel increased significantly compared with the concentration in fasting state. 2) Mean increment or percent increment in postprandial plasma gastrin concentration after the ingestion of sesame gruel was not significantly different from that after the control meal, i.e. the glutinous rice gruel. It is inferred from the above results that the ingestion of sesame contained in sesame gruel may have no significant influence on gastrin release in normal human subjects.

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위의 충만유무에 의한 간신티그램영상의 변화 (Effect of Gastric Filling on the Images of Hepatic Scintigraphy)

  • 이정숙;최민석;성천모;이재용;이계희;손인
    • 대한핵의학회지
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    • 제23권2호
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    • pp.189-193
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    • 1989
  • To observe the effect of gastric filling on the images of hepatic scintigraphy, we performed hepatic scintigraphy using $^{99m}Tc-tin$ colloid in twenty patients both in the fasting state and after meal, and made the visual comparison of both images. We found that gastric filling could cause some of the following changes in individual patients. 1) In the anterior view, the distance between the liver and the spleen increased and the interlobar notch of the inferior hepatic border was obliterated. The spleen was displaced downwards, its radioactivity in the upper medial part was reduced, and its upper pole was laterally displaced. 2) In the posterior view, the left lobe of the liver was separated from the spleen and the distance between the liver and the spleen increased. 3) In the right lateral view, the notch separating the right and the left lobes of the liver was well demarcated. 4) In the left lateral view, the spleen was separated from the liver and the distance between the liver and the spleen increased. The shape of the spleen was also changed. In case of the follow-up study, above changes should make one consider the possibility of the effect of gastric filling.

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단미 한약 복용중 발견한 Gilbert's syndrome 2예 임상고찰 (Report on Two Cases of Gilbert's Syndrome Found in the Process of Administering Herbs)

  • 이종덕;김동웅
    • 동의생리병리학회지
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    • 제28권6호
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    • pp.657-661
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    • 2014
  • Gilbert's syndrome is one that shows a benign course with intermittent unconjugate hyperbilirubinemia without any evidence of hepatobiliary tract disease or hemolysis. It is often found in a health examination or blood laboratory test by chance. In particular, patients who are taking drugs, including herbal medicine should be careful for their medication due to the possibility of associations with changes in liver function because of drug metabolism, sometimes they have to quit the use of the medication for a certain period and often they should get an additional test. Two male patients increased serum total bilirubin level without other systemic symptoms in screening test for clinical herb medicine pharmacokinetics study. Therefor they was diagnosed with suspected Gilbert's syndrome. They had been calory deprivation test with 24 hours fasting state. They also performed liver function test and ultrasonogram for evaluation of hepatobiliary tract disease. Total serum bilirubin was markedly increased, especially unconjugate bilirubin level higher over the two times than base line after they had been calory deprivation for 24 hours, They was not found another abnormality all laboratory results and physical examination. This study is a report on two cases of hyperbilirubinemia, diagnosed as Gilbert's syndrome, which were found in the process of a clinical pharmacokinetic study of a decoction of medicinal herbs.

A Study on Perceived Weight, Eating Habits, and Unhealthy Weight Control Behavior in Korean Adolescents

  • Yu, Nan-Sook
    • International Journal of Human Ecology
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    • 제12권2호
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    • pp.13-24
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    • 2011
  • This study compared actual weight with perceived weight, described the prevalence of unhealthy weight control behavior, determined the differences in psychological and personal variables between participants that reported unhealthy weight control behavior and those who did not, and examined the relationship of eating habits to unhealthy weight control behavior for Korean adolescents. The study population consisted of a nationally representative sample of middle and high school students who completed the Fifth Korea Youth Risk Behavior Web-based Survey (KYRBWS): Fifth in 2009. Among the 75,066 participants of KYRBWS, 35,473 (n = 18,851 girls and 16,622 boys) were eligible for a research focused on unhealthy weight control behavior. The results of this research were as follows: First, there were considerable discrepancies (45.1% of girls and 32.8% of boys) between the perceived weight and the actual weight. Second, overall, unhealthy weight control behavior was more prevalent in girls and fasting was the most commonly reported behavior. Third, participants that reported unhealthy weight control behavior scored significantly lower on scaled measures of happiness, health, academic achievement, and economic status; in addition, they scored higher on stress measures. Fourth, girls and boys shared common protective factors of having breakfast and vegetables more often, perceiving their weight as underweight rather than overweight, and having a correct weight conception. Protective factors unique to girls were having lunch and dinner more often. Girls and boys shared common risk factors of the consumption of soda, fast food, instant noodles, and snacks more often, while consumption of fruit more often was a risk factor only for girls. The improvement of protective factors and minimization of risk factors through Home Economics classes (and other classes relevant to health) may mitigate unhealthy weight control behavior of adolescents.

카베딜롤(25mg)정제의 생물학적 동등성 및 약물동태연구 (Bioequivalence and Pharmacokinetics of Carvedilol (25mg) Tablets in Volunteers)

  • 우수경;김호순;강종성;권광일
    • 약학회지
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    • 제45권6호
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    • pp.650-655
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    • 2001
  • Carvedilol is a nonselective $\beta$-blocking agent with vasodilating properties that are attributed mainly to its blocking activity at $\alpha$$^{1}$-receptors. Carvedilol is used in the treatment of mild to moderate hypertention and angina pectoris and is often used in combination with other drugs. This study was carried out to evaluate the bioequivalence and pharmacokinetics of two carvedilol 25mg tablet formulations according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty healthy volunteers are enrolled and received a single dose (25mg as carvedilol) of each drug in the fasting state, in a randomized 2-way crossover design. After oral administration, blond samples were collected for a period of 30 hours. Plasma concentrations of carvedilol were determined by a rapid and sensitive HPLC method with spectrofluorometric detection. The major pharmacokinetic parameters such as AU $C_{0-}$30hr/, AU $C_{inf}$ , $C_{max}$, $T_{max}$, $t_{1}$2 / Cl/F and V $_{\beta}$//F were calculated. ANOVA test and t-test were utilized for the statistical analysis of each parameter. The results showed that the differences in AU $C_{0-}$30hr/, $C_{max}$ and $T_{max}$ between two were ~5.66, 1.74 and 0.00%, respectively. Minimum detectable differences ($\Delta$) at $\alpha$=0.05 were less than$\pm$ 20% except $T_{max}$ (8.44, 18.36, and 33.86%, respectively). The 90% confidence intervals of all parameters were within $\pm$20% (-10.60~ -0.72, -9.00~12.49 and -19.81~19.81%, respectively). Therefore, it is concluded that the two formulations are bioequivalent for both the extent and the rate of absorption after single dose administration.ation.ion.ion.ation.ion.n.

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플루옥세틴 캅셀제의 지원자에 대한 생체이용율 및 대사율 비교 (Comparative Bioavailability and Metabolism of Two Capsule Formulations of Fluoxetine in Human Volunteers)

  • 강원구;박용순;조규행;최준식;권광일
    • 약학회지
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    • 제42권5호
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    • pp.513-518
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    • 1998
  • Fluoxetine is a nontricyclic antidepressant which blocks serotonin reuptake selectively. Its N-demethyl metabolite, norfluoxetine is also selective inhibitor of serotonin uptake . This study was carried out to compare the bioavailability of Myung-in fluoxetine (20mg/cap.) with that of Prozac$^{\circde{R}}$. The bioavailability was conducted on 24 healthy volunteers who received a single dose (80mg) of each drug in the fasting state, in a randomized balanced 2-way crossover design. After closing, serial blood samples were collected for a period of 48 hours, Plasma was analyzed for fluoxetine and norfluoxetine by a sensitive and validated HPLC assay. The major pharmacokinetic parameters ($AUC_{0-48\;hr}$, Cmax, Tmax , $AUC_{inf.}$, MRT. $T_{1/2}$, Vd and Cl) were, calculated from the plasma fluoxetine concentration-time data of each volunteer. The microcomputer program, 'WinNonlin' was used for compartmental analysis. A two-compartment model with first-order input, first-order output and no lag time was chosen as the most appropriate pharmacokinetic model. The data were best described by using a weighting factor of $1/y^2$. Though the plasma fluoxetine concentrations of Myung-in fluoxetine were higher than those of Prozac$^{\circde{R}}$ at all observed time from 7.9% to 16.9% (P<0.05 at 6.7 and 10 hr), the bioavailability of Myung-in fluoxetine appeared to be bioequivalent with that of Prozac$^{\circde{R}}$. There were no statistical significant differences between the two drugs in all pharmacokinetic parameters including $AUC_{0-48\;hr}$ of norfluoxetine.

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저항전분이 인체 혈당 조절기능에 미치는 영향 (Effect of Resistant Starch on Human Glycemic Response)

  • 이영희;오승호
    • 대한지역사회영양학회지
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    • 제9권4호
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    • pp.528-535
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    • 2004
  • In order to observe the effects of resistant starches on human glycemic response, nine female university students were investigated using cellulose (CED), resistant starch 3 (RS3D) and resistant starch 4 (RS4D) diets. Each woman's blood sugar and insulin, triacylglycerol and free fatty in plasma concentration were measured at fasting state, then 15, 30, 45, 60, 75, 90 and 120 minute after each test diet feeding. Glycemic indices of the Cellulose diet (CED: 57.9 $\pm3.00$), the Resistant starch 3 diet (RS3D: 52.6 $\pm7.9$) and the Resistant starch 4 diet (RS4D: 52.9 $\pm10.2$) were similar to each other, but they were significantly lower in comparison with those of white wheat bread diet (WWBD: 100). Insulinemic indices of the CED (49.8 $\pm8.2$), RS3D (50.0 $\pm7.3$) and RS4D (72.4 $\pm7.7$) were significantly lower in comparison with the white wheat bread diet (WWBD: 100), but among the dietary fiber diets, the insulinemic index of RS4D was significantly higher than the CED and the RS3D. Plasma triacylglycerol contents of the CED, RS3D and RS4D including WWBD showed gradual increase in tendency after lowering in early stage of each test diet feeding, but not significantly different in each dietary fiber added diet. Plasma free fatty acid contents of the CED, RS3D and RS4D including WWBD showed gradual decrease in tendency after each test diet feeding, but not significantly different by each dietary fiber added diet. In above results, we speculate that resistant starch 3 controls rapid elevation of blood sugar by delaying intestinal digestion and absorption of cellulose, but the result appears to be different from RS4 in comparison. Thus, RS3 intakes may contribute to the diet therapy of diabetic humans, but more studies on RS4 is needed in the future. (Korean J Community Nutrition 9(4): 528∼535, 2004)

건강신념모델 기반 중재연구가 당뇨환자의 건강행위와 생리적지표에 미치는 효과를 중심으로 한 체계적 문헌고찰 (A Systematic Review Focused on Health Behavior and Physiological Indicators of Diabetic Patients in Interventional Studies Based on Health Belief Model)

  • 노은영;조윤정;이예원;윤선영
    • Journal of Korean Biological Nursing Science
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    • 제22권1호
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    • pp.1-10
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    • 2020
  • Purpose: Diabetes Mellitus (DM) is a leading cause of death with a prevalence rate of 12.4% in South Korea. Self-management is crucial for patients with DM, because many studies have reported that self-management intervention based on the Health Belief Model (HBM) is effective. The purpose of this study was to investigate the current state of HBM based intervention studies and the components and effects of the theories used in the study for diabetes patients. Methods: A systematic review was conducted using the Pubmed, Cochrane Library and Embase databases from January 2009 to May 2019. We reviewed characteristics of intervention based on the HBM in randomized controlled clinical trials (RCTs), quasi-experimental study intervention. Results: Eight studies published in English between 2009 and 2019 were included in this review. The key components of the health behavior promotion program applied to the DM patients were perceived susceptibility, perceived severity, perceived benefits, perceived barriers and self-efficacy. The intervention based on these components has reported to significantly increase the health behavior change, likelihood of taking health action and improve physiological indicators (HbA1c, and fasting blood sugar etc.). Conclusion: This study highlighted the importance of intervention programs based on the HBM for DM patients.