• Nutritional Sciences
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• v.1 no.1
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• pp.70-76
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• 1998

This study was designed to investigate the relationship between body mass index (BMI) and dietary intake, and the relationship between BMI and plasma lipid levels in Korean adults. This study was conducted from January 1 to December 31 of 1997. It consisted of 3781 subjects (men 2402, women : 1379) with the majority between the ages of 40 and 59. The dietary assessment was based upon a twenty-four-hour food record. Subjects were classified into one of four reference BMI groups : underweight ($\leq 20 kg/m^2$), normal (20.1-25.0 kg/$m^2$), overweight (25.1-30.0 kg/$m^2$), and obese (>30 kg/$m^2$). The biochemical assessment included measurements of plasma total cholesterol (TC), HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), triglyceride (TG), lipoprotein (a), and plasminogen activator inhibitor-1 (PAI-1). The BMI study showed that 60.5% of the men measured were normal and 32.6% of the men were overweight and/or obese subjects. Sixty-four percent of the women were normal and 20.3% of the women measured were overweight and/o. obese subjects. With respect to the daily energy intake of the men and women subjects, the levels of daily energy intake appeared to increase as values of BMI increased. Men of the overweight group had significantly higher protein, fat and cholesterol intake than those of the normal or the underweight groups. The alcohol intake of the men in the overweight group was also significantly higher than that of the men in the underweight group. With respect to percent energy intake of macronutrients, there was no significant difference between the four BMI groups and percent energy intake for all the subjects in the study. The ratio of percent energy intake of carbohydrates : protein : fat : alcohol of the normal women group was 62 : 17 : 20 : 1, respectively. Women apparently had a higher intake of carbohydrates than men (52 : 17 : 19 : 10). With respect to the levels of plasma TC, LDL-C, TG, and HDL-C, the levels of plasma TC, LDL-C and TC appeared to increase as the values of BMI increased, while the level of HDL-C appeared to decrease as values of BMI increased. Levels of lipoprotein (a) appeared to be inversely related to the values of BMI, and levels of PAI-1 appeared to increase as values of BMI increased. The results of this study demonstrate that there is a relationship between dietary intake and BMI, and that there is a relationship between BMI and blood lipids levels.

• Journal of Nutrition and Health
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• v.37 no.1
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• pp.61-67
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• 2004

This study was conducted to investigate the choline intake of Korean adults for the purpose of preparing a basal data required for the establishment of choline adequate intake (AI). The subjects of 56 Korean young adults were recruited from college students of 20 to 30 years old in Daejeon city. The aliquots of foods that the subjects ate for one day were collected with use of duplicate food collection method and choline content of one day meal directly was analyzed with the use of enzymatic method. Choline intakes of male subjects were in the range of 353.5∼1222.5 mg and those of female subjects were in the range of 213.1 ∼ 722.3 mg. Mean intakes of choline were 658.2 $\pm$ 243.9 mg/day in male subjects and 423.3 $\pm$ 133.6 mg/day in female, therefore choline intake of men was about 200mg higher than that of women. Median value in total subjects was 496 mg, male's median was 608.8 mg, female's median was 419.9 mg. When the subjects were devided into 4 groups by choline intake, as less than 75%, 75∼100%, 100∼125% and over 125% based on choline AI of USA (males: 550 mg, females: 425 mg), there was no significant difference between men (64.3%) and wemen (67.9%) in the distribution of the subjects whose choline intake is under the range of 75∼125% AI of USA. However, 10.7% of men and 21.4% of female had choline intake less than 75% AI of USA while the cases of choline intake higher than 125% AI were 25% in male and 10.7% in female. Thus, it is assumed that female case in choline-deficient state would be two times more than male. When adjusted by body weight, choline intake was 9.5 $\pm$ 3.4 mg/kg in men,8.1 $\pm$ 3.1 mg/kg in women and 8.8 $\pm$ 3,3 mg/kg in total subjects. And choline intake per 1,000 kcal of men, women and total subjects were 277.1 $\pm$ 78.4 mg, 275.9 $\pm$ 62.1 mg and 276.5 $\pm$ 70.1 mg respectively. From these results, it is suggested that these levels of 276.5 $\pm$ 70.1 mg/ 1,000 kcal or 8.8 $\pm$ 3.3 mg/kg B.W. can be used as a reference value for the establishment of AI of choline for Korean, because overall choline intake of these subjects was not in lower state compared to other nutrients intakes obtained from calculation of the food the subjects had taken.

• Nutrition Research and Practice
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• v.9 no.2
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• pp.192-198
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• 2015

BACKGROUND/OBJECTIVES: Vitamin E is a fat-soluble vitamin and functions primarily as a lipid antioxidant. Inadequate vitamin E status may increase risk of several chronic diseases. Thus, the objectives of this study were to estimate intake and plasma concentration of each tocopherol and to evaluate vitamin E status of Korean adults. SUBJECTS/METHODS: Three consecutive 24-h food recalls and fasting blood samples were collected from healthy 20- to 59-y-old adults (33 males and 73 females) living in the Seoul metropolitan area, South Korea. ${\alpha}$-, ${\beta}$-, ${\delta}$-, and ${\gamma}$-tocopherol intakes and plasma concentrations of tocopherols (${\alpha}$-, ${\delta}$-, and ${\gamma}$- tocopherol) were analyzed by gender. RESULTS: Dietary vitamin E and total vitamin E intake (dietary plus supplemental vitamin E) was $17.68{\pm}14.34$ and $19.55{\pm}15.78mg$ ${\alpha}$-tocopherol equivalents, respectively. The mean daily ${\alpha}$-tocopherol, and ${\gamma}$-tocopherol intakes were $3.07{\pm}2.27mg$ and $5.98{\pm}3.74mg$, respectively. Intakes of total vitamin E and each tocopherol of males were significantly higher than those of females (P < 0.05). Plasma ${\alpha}$-tocopherol concentration was $15.45{\pm}10.16$ of males and $15.00{\pm}4.54{\mu}mol/L$ of females, respectively. There were no significant differences in plasma tocopherol concentrations by gender ($P{\geq}0.05$). Plasma ${\alpha}$-tocopherol was negatively correlated with ${\gamma}$-tocopherol intake (P < 0.05). Twenty-three percent of the subjects had plasma ${\alpha}$-tocopherol concentrations < $12{\mu}mol/L$ indicating a biochemical deficiency of vitamin E. Approximately 8% and 9% of these participants had plasma ${\alpha}$-tocopherol:total lipid ratio less than $1.59{\mu}mol/mmol$ and plasma ${\alpha}$-tocopherol:total cholesterol ratio less than $2.22{\mu}mol/mmol$, respectively, which are also indicative of vitamin E deficiency. CONCLUSIONS: Vitamin E intakes of Korean adults were generally adequate with the Korean Dietary Reference Intakes for vitamin E. However, ${\alpha}$-tocopherol intake was lower than that reported in other countries, and 23% of the subjects in the current study were vitamin E deficient based on plasma ${\alpha}$-tocopherol concentrations.

• Journal of Pharmaceutical Investigation
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• v.35 no.5
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• pp.323-328
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• 2005

The purpose of the present study was to evaluate the bioequivalence of two torasemide tablets, Torem tablet (Roche Korea Co., Ltd., Korea, reference drug) and Boryung Torsemide tablet (Boryung Pharmaceutical Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (furosemide) to human serum, serum samples were extracted using 5 mL of ethyl acetate. Compounds were analyzed by reverse-phase HPLC method with UV detection. This method showed linear response over the concentration range of 0.05 ug/mL with correlation coefficient of 0.999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ug/mL which was sensitive enough for pharmacokinetic studies. Twenty-eight healthy male Korean volunteers received each medicine at the torasemide dose of 20 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of torasemide were monitored by an HPLC-UV for over a period of 12 hr after the administration. $AUC_{t}$(the area under the serum concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum serum drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the serum 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 Boryung Torsemide/Torem were log 0.97-10g 1.03 and log 0.93log 1.12, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Boryung Torsemide tablet and Torem tablet are bioequivalent.

• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.131-136
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• 2006

The purpose of the present study was to evaluate the bioequivalence of two losartan tablets, $Cozaar^{TM}$ tablet (MSD Korea. Co., Ltd., Seoul, Korea, reference drug) and $Losartan^{TM}$ tablet (DaeWon Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the losartan kalium dose of 100 mg in a $2\;{\time}\;2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of losartan were monitored by an LC-MS/MS for over a period of 12 hr after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (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 $AUC_t$ 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 $Cozaar^{TM}/Losartan^{TM}$ were $log\;0.97{\sim}log\;1.12\;and\;log\;0.93{\sim}log\;1.23$, respectively. These values were within the acceptable bioequivalence intervals of $log\;0.80{\sim}log\;1.25$. Taken together, our study demonstrated the bioequivalence of $Cozaar^{TM}$ and $Losartan^TM$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.29 no.2
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• pp.145-149
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• 1999

Bioequivalence of two cefixime capsules, test drug ($Cepirin^R$ capsule: Cheiljedang Corp.) and reference drug ($Suprax^R$ capsule: Dong A Pharm. Com.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy volunteers were divided randomly into two groups and administered the drug orally at the dose of 400 mg as cefixime in a $2{\times}2$ crossover study. There was a 1-week washout period between the administrations. Blood samples were taken at predetermined time intervals for 12 hour and the plasma concentration of cefixime was determined with a HPLC method. $AUC_{0-12hr}$ (area under the plasma concentration-time curve form time zero to 12 hour), $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were estimated from the plasma drug concentrationtime data. Analysis of variance (ANOVA) revealed no difference in $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences of these parameters between the formulations were less than 20% (i.e., 8.62, 11.10 and 0.00% for $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$,respectively). The powers $(1-{\beta})$ for $AUC_{0-12hr}$ $C_{max}$ and $T_{max}$ were over 0.9. Minimal detectable difference $({\Delta})$ at ${\alpha}=0.05$, $1-{\beta}=0.8$ were less than 20% (i.e., 12.84, 11.05 and 17.99% for $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals $({\delta})$ for these parameters were also within ${\pm}20%$ (i.e., $-0.53{\le}{\delta}{\le}17.76$, $3.23{\le}{\delta}{\le}18.97$ and $-12.81{\le}{\delta}{\le}12.81$ for $AUC_{0-12hr}$, $C_{max}$ and $T_{max}$, respectively). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating the two formulations of cefixime were bioequivlent.

• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.143-148
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• 2006

Finasteride $[N-(1, 1-dimethylethyl)-3-oxo-4-aza-5{\alpha}-androst-1-ene-17{\beta}-carboxamide]$ is a 4-aza-3-oxosteroidal inhibitor of human $5{\alpha}-reductase$. The purpose of the present study was to evaluate the bioequivalence of two finasteride tablets, $Proscar^{\circledR}$ (MSD Korea Ltd.) and Procare (Hana Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of finasteride from the two finasteride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $23.7\;{\pm}\;2.24$ years in age and $67.2\;{\pm}\;8.55\;kg$ in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After two tablets containing 5 mg as finasteride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of finasteride in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Proscar^{\circledR}$, were 6.39, 4.65 and -13.9% for $AUC_t,\;C_{max},\;and\;T_{max},$ respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.800 to log 1.25 $(e.g.,\;log\;0.990{\sim}log\;1.14\;and\;log\;0.977{\sim}log\;1.13 for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procare tablet was bioequivalent to $Proscar^{\circledR}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.41 no.5
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• pp.317-322
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• 2011

Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.41 no.2
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• pp.117-123
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• 2011

Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

• Journal of Nuclear Fuel Cycle and Waste Technology(JNFCWT)
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• v.8 no.4
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• pp.293-301
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• 2010

Optical fiber cable, as a sensor, was installed on the wall of KAERI(Korea Atomic Energy Research Institute) Underground Research Tunnel(KURT) in order to monitor the physical stability of the tunnel, which was constructed for technical development and demonstration of radioactive waste disposal. This monitoring system has two simultaneous measurements of temperature and strain over time using Brillouin backscatter. According to the results of the monitoring from Jan. 2008 to Nov. 2009, there is no significant displacement or movement at the tunnel wall However, the cumulative volume of total strain increased slightly as time passes with the comparison of the reference observation, which was measured in Jan. 2008. The change in cumulative volume of total strain indicates that the strain level had been affected by saturation and de-saturation phenomena due to groundwater fluctuation at several points at KURT. This system is based on the distributed sensing technique concept, not point sensing. By using this system, a displacement can be detected with the range from $20{\mu}{\varepsilon}$ to $28,000{\mu}{\varepsilon}$ every 1m interval in minimum. A temperature variation can be monitored at every 0.5m interval with the resolution of 0.01 in minimum. Based on the study, this monitoring system is potentially applicable to long term monitoring systems for radioactive waste disposal project as well as other structures and underground openings.