• 한국임상약학회지
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• 제22권1호
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• pp.9-12
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• 2012

Background: Cefcapene pivoxil hydrochloride, is an ester-type oral cephem antibiotic. This study was performed to compare the pharmacokinetics and evaluate the bioequivalence of two cefcapene pivoxil hydrochloride 75 mg formulations. Method: In a randomized $2{\times}2$ crossover study, sixty healthy male volunteers were randomly assigned into two groups. After a single dose of 75 mg cefcapene pivoxil hydrochloride oral administration, blood samples were collected at specific time intervals from 0-12 hours. The plasma concentrations of cefcapene pivoxil hydrochloride were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The pharmacokinetic parameters such as $AUC_{last}$, $AUC_{inf}$ and $C_{max}$, were calculated and the 90% confidence intervals for test/reference ratio for pharmacokinetic parameters were obtained by analysis of variance on logarithmically transformed data. Results: The mean value for $AUC_{last}$ in test and reference drug was $4053.1{\pm}876.5\;ng{\cdot}hr/mL$ and $3595.7{\pm}1029.1\;ng{\cdot}h/mL$, respectively. The mean value for $C_{max}$ in test and reference drug was $1324.9{\pm}321.4$ ng/mL and $1159.1{\pm}335.9$ ng/mL, respectively. The 90% confidence intervals of the $AUC_{last}$ and $C_{max}$ ratio for test drug and reference drug were log 1.09-log1.22 and log 1.09-log1.24, respectively. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. Conclusion: This single dose study found that the test and reference products met the regulatory criteria for bioequivalence in these health volunteers. Both formulations were safe and well tolerated in 75 mg of cefcapene pivoxil hydrochloride.

• Korean Journal of Acupuncture
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• 제27권1호
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• pp.1-12
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• 2010

Objectives: The purpose of this study is to gain the objective indicators for the classification of hypertension by oriental medical pulse diagnosis, through finding out the parameters which can distinguish the pulse of hypertensive patient from that of normal subject, and characterizes the wiry pulse of hypertension. Methods: 30-59 yr, male, 946 healthy volunteers and 35 hypertensive patients were enrolled in this study. All the hypertensive patients were taking medicine to control the blood pressure and the blood pressure of the hypertension group was not statistically different from that of the normal healthy group. Data were acquired using 3 dimensional pulse imaging analyser(DMP-3000, DAEYOMEDI, KOREA) and analysed according to the age bands and the applied pressure levels. Results: 1. RAI/t, w/t and t2/t decreased with the levels of applied pressure and increased with age in the normal healthy group, not in the hypertension group. 2. RAI/t, w/t, t2/t were significantly higher in the hypertension group than the normal healthy group in the 30-age band, and elasticity coefficient was higher in the hypertension group than the normal healthy group in the 40-age band. 3. Researches on the patients without hypotensive agents are needed to figure out whether these parameters are the components of hypertensive wiry pulse. Conclusions: Analysing the radial pulse at 5 applied pressure levels using 3 dimensional pulse imaging analyser may be useful to differentiate the pulses of the hypertensive patients from those of the normal subjects, and characterize the hypertension.

• Journal of Preventive Medicine and Public Health
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• 제37권4호
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• pp.373-380
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• 2004

Objectives : There has been gradually increasing concern about the adverse health effects of electromagnetic radiation originating from cell phones which are widely used in modern life. Cell phone radiation may affect human health by increasing free radicals of human blood cells. This study has been designed to identify DNA damage of blood cells by electromagnetic radiation caused by cell phone use. Methods : This study investigated the health effect of acute exposure to commercially available cell phones on certain parameters such as an indicator of DNA damage for 14 healthy adult volunteers. Each volunteer during the experiment talked over the cell phone with the keypad facing the right side of the face for 4 hours. The single cell gel electrophoresis assay (Comet assay), which is very sensitive in detecting the presence of DNA strand-breaks and alkali-labile damage in individual cells, was used to assess peripheral blood cells (T-cells, B-cells, granulocytes) from volunteers before and after exposure to cell phone radiation. The parameters of Comet assay measured were Olive Tail Moment and Tail DNA %. Results : The Olive Tail Moment of B-cells and granulocytes and Tail DNA % of B-cells and granulocytes were increased by a statistically significant extent after 4-hour use of a cell phone compared with controls. Conclusion : It is concluded that cell phone radiation caused the DNA damage during the 4 hours of experimental condition. Nonetheless, this study suggested that cell phone use may increase DNA damage by electromagnetic radiation and other contributing factors.

• Archives of Pharmacal Research
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• 제27권7호
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• pp.806-810
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• 2004

Metformin is a biguanide antihyperglycemic agent often used for the treatment of non-insulin dependent diabetics (NIDDM). In this study, the pharmacokinetics and pharmacodynamics of metformin were investigated in Korean healthy volunteers during a fasting state for over 10 h. In order to evaluate the amount of glucose-lowering effect of metformin, the plasma concentrations of glucose were measured for a period of 10 h followed by the administration of metformin (oral 500 mg) or placebo. In addition, the concentration of metformin in blood samples was determined by HPLC assay for the drug. All volunteers were consumed with 12 g of white sugar 10 minutes after drug intake to maintain initial plasma glucose concentration. The time courses of the plasma concentration of metformin and the glucose-lowering effect were analyzed by nonlinear regression analysis. The estimated $C_{max}$, $T_{max}$, $CL_{t}$/F (apparent clearance), V/F(apparent volume of distribution), and half-life of metformin were 1.42$\{pm}$0.07 $\mu\textrm{g}$/mL, 2.59$\{pm}$0.18h, 66.12$\{pm}$4.6 L/h, 26.63 L, and 1.54 h respectively. Since a significant counterclock-wise hysteresis was found for the metformin concentration in the plasma-effect relationship, indirect response model was used to evaluate pharmacodynamic parameters for metformin. The mean concentration at half-maximum inhibition $IC_{50}$, $k_{in}$, $k_{out}$ were 2.26 $\mu\textrm{g}$/mL, 83.26 $H^{-1}$, and 0.68 $H^{-1}$, respectively. Therefore, the pharmacokinetic-pharmacodynamic model may be useful in the description for the relationship between plasma concentration of metformin and its glucose-lowering effect.

• 대한본초학회지
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• 제24권1호
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• pp.133-139
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• 2009

Objectives : This study was designed to investigate the effects of alcoholic fermentation extract from ovary and rind of pear on human skin. Methods : We investigated the effects of samples on human skin in terms of clinical trial. 32 of healthy volunteers, who lived in mokpo participated in clinical trial. Effects of sample on hygroscopicity and water-holding capacity were investigated. Sebum, moisture, scabrousness and desquamation were also investigated. Facial massages were conducted 8 times in each volunteers. Results : Single treatment group showed elevated levels of hygroscopicity (Normal : 106.4$\pm$2.1%, vs Pear : 114.1$\pm$6.2) and water-holding capacity (Normal : 87.1$\pm$4.4%, vs Pear : 96.2$\pm$1.3) on forearm of 16 volunteers respectively. In addition, massage group using sample showed elevated moisture (Control : 3.8$\pm$5.8%, vs Sample : 15.2$\pm$4.7%) and lowered scabrousness levels (Control : -12.3$\pm$4.4%, vs Sample : -22.0$\pm$5.2%) significantly. However, the levels of sebum did not affected by sample. Conclusions : These result suggest that alcoholic fermentation extract from ovary and rind of pear has moisturizing effect on human skin.

• 대한한의학회지
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• 제42권2호
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• pp.50-61
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• 2021

Objectives: The object of this study was to examine whether there was a significant difference between morning and afternoon in heart rate variability(HRV) in healthy Korean adults. In addition, the correlation between the characteristics of the subjects and the test results was analyzed. Methods: From January 8, 2021 to January 29, 2021, twenty healthy subjects received short-term HRV test once in the morning(6:00~12:00) and twice in the afternoon(12:00~18:00). We used IBM SPSS Statistics 27 to test for statistical significance. Results: The mean heart rate and PSI decreased significantly and SDNN increased significantly in the morning compared to the afternoon. There was no significant difference except RMSSD in HRV conducted at 2 hours intervals in the afternoon. Age had a significant difference in SDNN and TP, and exercise in average heart rate. Age, weekly exercise frequency, and monthly drinking frequency showed significant correlations with HRV indicators. As a result of multiple regression analysis, monthly drinking frequency was a variable that had a significant influence on TP. Conclusions: The results of the tests performed with short interval were relatively consistent, and when comparing the results of the afternoon and the next morning, there were significant differences in several indicators. In the future, the number of HRV measurements should be increased and a larger-scale follow-up study including more subjects will be needed.

• Biomolecules & Therapeutics
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• 제13권2호
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• pp.118-122
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• 2005

The objective of the present investigation was to study pharmacokinetics of promethazine in Korean healthy subjects using a validated HPLC method. The HPLC analysis was performed on a Capcell Pak CN column with a mixture of acetonitrile-0.02M potassium dihydrogen phosphate (42:58, v/v, pH 6.0) and the analyte was quantified with UV detection at 251 nm. The calibration curve of the drug was linear over the range of 1-40ng/mL in human serum and the limit of quantification (LOQ) was 1 ng/mL. This analytical method was validated and shown to be specific, accurate, precise and reproducible. This method was applied to pharmacokinetic study of promethazine in Korean healthy volunteers following an oral administration of two 25 mg Himazin tablets (50 mg promethazine ${\cdot}$HCI) after overnight fasting. Serum samples were collected at given intervals over a 36-hour period (12 points) and pharmacokinetic parameters were determined from serum concentration-time profile using WinNonlin program. The estimated $AUC_{0__\infty}$, $AUC_{0_\infty}$, $C_{max}$, $T_{max}$ and $t_{1/2}$ of promethazine obtained from Korean healthy subjects were 103.84 ${\pm}$84.30 ng${\cdot}$hr/mL, 87.94${\pm}$81.02 ng${\cdot}$hr/mL, 13.43${\pm}$10.92 ng/mL, 2.00${\pm}$1.16 hr and 5.88${\pm}$3.47 hr, respectively.

• Tuberculosis and Respiratory Diseases
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• 제76권6호
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• pp.269-275
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• 2014

Background: The six-minute walk test has been widely used in people with chronic cardiopulmonary disorders as an outcome assessment with regards to therapeutic or prognostic determinants. This study was undertaken to determine the six-minute walk distance (6MWD) in a sample of healthy Koreans and to create a reference equation. We also compared the 6MWD of our cohort with previously published equations. Methods: Two hundred fifty-nine healthy subjects (95 males) aged 22-59 years performed two walking tests using a standardized protocol. 6MWD was defined as the greatest distance achieved from the two tests. The effect of anthropometrics on the 6MWD was also investigated. Results: The average 6MWD was $598.5{\pm}57.92m$, with significantly longer distances by males ($628.9{\pm}59.51m$) than females ($580.9{\pm}47.80m$) (p<0.001). Age, height, weight, and body mass index were significantly correlated with 6MWD in univariate analysis. Stepwise multiple regression showed height to be single independent predictor of 6MWD ($r^2$=0.205, p<0.001). The reference equations derived in Caucasian and North African populations tend to overestimate the distance walked by Korean subjects, while Asian equations underestimate it. Conclusion: The average 6MWD in these Korean populations was 600 m. The regression equation revealed that individual's height was the most significant predictor of distance, explaining 20.5% of the distance variance.

• The Korean Journal of Physiology and Pharmacology
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• 제28권2호
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• pp.153-164
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• 2024

This study aimed to identify metabolic biomarkers and investigate changes in intestinal microbiota in the feces of healthy participants following administration of Lactococcus lactis GEN-001. GEN-001 is a single-strain L. lactis strain isolated from the gut of a healthy human volunteer. The study was conducted as a parallel, randomized, phase 1, open design trial. Twenty healthy Korean males were divided into five groups according to the GEN-001 dosage and dietary control. Groups A, B, C, and D1 received 1, 3, 6, and 9 GEN-001 capsules (1 × 10¹¹ colony forming units), respectively, without dietary adjustment, whereas group D2 received 9 GEN-001 capsules with dietary adjustment. All groups received a single dose. Fecal samples were collected 2 days before GEN-001 administration to 7 days after for untargeted metabolomics and gut microbial metagenomic analyses; blood samples were collected simultaneously for immunogenicity analysis. Levels of phenylalanine, tyrosine, cholic acid, deoxycholic acid, and tryptophan were significantly increased at 5-6 days after GEN-001 administration when compared with predose levels. Compared with predose, the relative abundance (%) of Parabacteroides and Alistipes significantly decreased, whereas that of Lactobacillus and Lactococcus increased; Lactobacillus and tryptophan levels were negatively correlated. A single administration of GEN-001 shifted the gut microbiota in healthy volunteers to a more balanced state as evidenced by an increased abundance of beneficial bacteria, including Lactobacillus, and higher levels of the metabolites that have immunogenic properties.

• 한국임상약학회지
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• 제26권4호
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• pp.312-317
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• 2016

Objective: Midazolam is mainly metabolized by cytochrome P450 (CYP) 3A. Inhibition or induction of CYP3A can affect the pharmacological activity of midazolam. The aims of this study were to develop a population pharmacokinetic (PK) model and evaluate the effect of CYP3A-mediated interactions among ketoconazole, rifampicin, and midazolam. Methods: Three-treatment, three-period, crossover study was conducted in 24 healthy male subjects. Each subject received 1 mg midazolam (control), 1 mg midazolam after pretreatment with 400 mg ketoconazole once daily for 4 days (CYP3A inhibition phase), and 2.5 mg midazolam after pretreatment with 600 mg rifampicin once daily for 10 days (CYP3A induction phase). The population PK analysis was performed using a nonlinear mixed effect model ($NONMEM^{(R)}$ 7.2) based on plasma midazolam concentrations. The PK model was developed, and the first-order conditional estimation with interaction was applied for the model run. A three-compartment model with first-order elimination described the PK. The influence of ketoconazole and rifampicin, CYP3A5 genotype, and demographic characteristics on PK parameters was examined. Goodness-of-fit (GOF) diagnostics and visual predictive checks, as well as bootstrap were used to evaluate the adequacy of the model fit and predictions. Results: Twenty-four subjects contributed to 900 midazolam concentrations. The final parameter estimates (% relative standard error, RSE) were as follows; clearance (CL), 31.8 L/h (6.0%); inter-compartmental clearance (Q) 2, 36.4 L/h (9.7%); Q3, 7.37 L/h (12.0%), volume of distribution (V) 1, 70.7 L (3.6%), V2, 32.9 L (8.8%); and V3, 44.4 L (6.7%). The midazolam CL decreased and increased to 32.5 and 199.9% in the inhibition and induction phases, respectively, compared to that in control phase. Conclusion: A PK model for midazolam co-treatment with ketoconazole and rifampicin was developed using data of healthy volunteers, and the subject's CYP3A status influenced the midazolam PK parameters. Therefore, a population PK model with enzyme-mediated drug interactions may be useful for quantitatively predicting PK alterations.