• Biomolecules & Therapeutics
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• 제15권2호
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• pp.118-122
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• 2007

This study was performed to evaluate the bioequivalency between the Osmetone$^{TM}$ Tablet (Myeongmoon Pharm. Co., Ltd.) as a test formulation and the Relafen$^{TM}$ Tablet (Handok Pharm. Co., Ltd.) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with Ultra-Violet (UV) detector. AUC$_t$, C$_{max}$ and T$_{max}$ were obtained from the time-plasma concentration curves, and log-transformed AUC$_t$ and C$_{max}$ and log-untransformed T$_{max}$ values for two formulations were compared by statistical tests and analysis of variation. AUC$_t$ was determined to be 897.8${\pm}$431.1 ug.hr/ml for the reference formulation and 902.3${\pm}$408.4 ug.hr/ml for the test formulation. The mean values of C$_{max}$ for the reference and test formulations were 24.2${\pm}$8.9 and 24.0${\pm}$9.5 ug/ml, respectively. The AUC$_t$ and C$_{max}$ ratios of the reference Relafen$^{TM}$ Tablet to the test Osmetone$^{TM}$ Tablet were +5.01% and -0.83%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for logtransformed AUC$_t$ and C$_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for AUC$_t$ and C$_{max}$ were located in ranges from log 0.80 to log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The Osmetone$^{TM}$ Tablet as the test formulation was considered to be bioequivalant to the Relafen$^{TM}$ Tablet used as its reference formulation, based on AUC$_t$ and C$_{max}$ values.

• Journal of Pharmaceutical Investigation
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• 제35권5호
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• pp.355-360
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• 2005

The purpose of the present study was to evaluate the bioequivalence of two cetirizine HCl tablets, Zyrtec tablet (UCB Pharm. Co., Ltd. Korea, reference product) and Zyrix tablet (Kukje Pharm. Co., Ltd., Korea, test product), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (diazepam), plasma samples were extracted using 1 mL of dichloromethane. Compounds extracted were analyzed by reverse-phase HPLC with ultra-violet detector. This method for determination cetirizine is proved accurate and reproducible with a limit of quantitation of 10 ng/mL in male plasma. Twenty-four healthy male Korean volunteers received each medicine at the cetirizine HCl dose of 10 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of cetirizine were monitored for over a period of 24 hr after the administration. AUC (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 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 for the log transformed data were acceptable range of log 0.8 to log 1.25 $(e.g.,\;log\;0.93-log\;1.08\;for\;AUC_{0-t},\;log\;0.91-log\;1.08\;for\;AUC_{0-{\infty}}\;and\;log\;1.01-log\;1.11\;for\;C_{max})$. The major parameters, AUC and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that Zyrix tablet is bioequivalent to Zyrtec tablet.

• 한국한의학연구원논문집
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• 제6권1호
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• pp.69-80
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• 2000

Objectives : Assuming that the characteristic of meridian system has been similar to this of electric potentials in human body and that measurements of electric potential at well(井穴) and sea(合穴) points in branches of the twelves meridians will be representative of measurements of the twelve meridians, to measure the electric potentials in twenty healthy volunteers when they were sleeping or waking respectively, to do significance test for electric potential of meridian system between hand and foot meridian, yin and yang meridian, exterior and interior of the body, and among the five elements. Methods : When twenty healthy volunteers were sleeping, their electric potentials of well and sea points in branches of the twelve meridians were simultaneously measured by physiograph. After a minute we measured them again, totally 5 times. And then when they were waking, their electric potentials were measured 5 times by the above method. Results : Measurements were analyzed by statistical t-test, we obtained that the left side electric potential of hand or yin meridian was significantly different from that of foot or yang meridian both sleeping and waking. The right side of electric potential was the same result as the left side's. Most of the t-test was significant between exterior and interior of the body, and among the five elements. That meaned that it was partly possible to apply the ancient theory of meridians to the study of electric potential at well and sea points in branches of the twelves meridians.

• Biomolecules & Therapeutics
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• 제14권1호
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• pp.50-55
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• 2006

The objective of the study was to evaluate the bioequivalency between the $Rozid^{TM}$ Tablet (Ilhwa Pharm. Co., Ltd.) as a test formulation and the $Rulid^{TM}$ Tablet (Handok Pharm. Co., Ltd) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with fluorescence detector. $AUC_t,\;C_{max}\;and\;T_{max}$ were obtained from the time-plasma concentration curves, and log-transformed $AUC_t\;and\;C_{max}$ and log-untransformed $T_{max}$ values for two formulations were compared by statistical tests and analysis of variation. $AUC_t$ was determined to be $63.30{\pm}25.57{\mu}g.hr/ml$ for the test formulation and $64.02{\pm}29.27mg.hr/ml$ for the reference formulation. The mean values of $C_{max}$ for the test and reference formulations were $5.07{\pm}2.14\;and\;5.53{\pm}2.60{\mu}g/ml$, respectively. The $AUC_t,\;and\;C_{max}$ ratios of the test $Rozid^{TM}$ Tablet to the reference $Rulid^{TM}$ Tablet were -1.12% and -8.32%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for log-transformed $AUC_t,\;and\;C_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for $AUC_t,\;and\;C_{max}$ were located in ranges from log 0.80 and log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The RozidTM Tablet as the test formulation was considered to be bioequivalent to the RulidTM Tablet used as its reference formulation, based on $AUC_t,\;and\;C_{max}$ values.

• 한국임상약학회지
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• 제19권1호
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• pp.23-31
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• 2009

The aim of this study was to evaluate the pharmacokinetic parameters of two risedronate preparations. The clinical assessment was conducted on 46 healthy volunteers who received one tablet (Risedronate sodium 35 mg/tablet) in the fasting state, in a randomized balanced $2{\times}2$ cross-over study design. After dosing of one tablet containing 35 mg risedronate sodium, blood samples were collected serially for a period of 48 hours. Plasma was analyzed for risedronate by using LC/MS/MS assay method. The analysis system was validated in specificity, accuracy, precision, and linearity. $AUC_t$, (the area under the plasma concentration-time curve from the zero-time to 48 hr) was calculated through the trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) were compiled from the plasma risedronate concentration-time data of each volunteer. No significant sequence effect was found for the pharmacokinetic parameters indicating that the cross-over design was properly performed. The 90 % - Confidence intervals of the $AUC_t$ ratio and the $C_{max}$ were from log 0.8752 to log 1.1888 and log 0.8457 to log 1.1478, respectively. These values were within the acceptable intervals between 0.80 and 1.25. Therefore, this study demonstrated that no statistically significant difference was identified with respect to the rate and extent of absorption.

• 가정과삶의질연구
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• 제25권1호
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• pp.127-144
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• 2007

This study was conducted for the purpose of analyzing volunteer workers' perceptions of and attitudes toward the behavior problems of the elderly residents after caring for the residents voluntarily at low-income nursing homes. Eleven male and female volunteers ranging from age 19 to 52 were asked how they felt about the elderly residents' behavior problems and what kind of behavioral problems they had experienced after doing volunteer works in the three chosen facilities. In particular, they were expected to explain what emotional changes they experienced during their volunteer service. In this study, it was observed that most of the elderly subjects experienced three categories of behavior problems: habitual, repetitious and unreasonable activities caused by the elderly residents' life span backgrounds, unexpected and/or abrupt behaviors resulting from gradual cognitive impairments, and physiological, awkward activities caused from gradual senility. The volunteers tend to believe that the elderly residents are naturally expected to act positively, since they have been provided with well- planned, regular care services such as bathing, counseling, activity programs, and religious guidances. On the other hand, some respondents stated that their experiences at the nursing homes caused them to form negative images of the elderly; they feel that the elderly are not helpful for giving advices on critical decisions, guiding and encouraging their daily lives, and offering any positive influences toward their own lives. Rather, they find themselves getting too much stressed as a result of their intimate contacts with demented or senile residents. Overall, in this study, it is proposed that education for confronting sudden abrupt behavior problems should be intensified more for female volunteers, since they tend to be more susceptible to emotional harassment resulting from the problem behaviors. It is also proposed that young volunteers who have not been systematically trained for confronting aggressive behaviors need to be separately assigned their roles in order to minimize the potential of confronting unseemly situations resulting from male residents whose mental health has deteriorated. Furthermore, it is also suggested that the combination of leisure-related activities for healthy residents and stressful intimate services for the frail residents be systematically planned and implanted for the volunteer program so that the volunteers can lessen the chances of suddenly finding themselves confronted with extremely abrupt agitations.

• Nutrition Research and Practice
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• 제4권3호
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• pp.203-207
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• 2010

This study investigated the effects of Oligonol intake on cortisol, interleukin (IL)-$1{\beta}$, and IL-6 concentrations in the serum at rest and after physical exercise loading. Nineteen healthy sedentary male volunteers participated in this study. The physical characteristics of the subjects were: a mean height of $174.2{\pm}2.7$ cm, a mean weight of $74.8{\pm}3.6$ kg and a mean age of $22.8{\pm}1.3$ years. Each subject received 0.5 L water with Oligonol (100 mg/day) (n = 10) or a placebo (n = 9) daily for four weeks. The body composition, the white blood cell (WBC) and differential counts as well as the serum cortisol, IL-$1{\beta}$, and IL-6 concentrations were measured before and after Oligonol intake. The cortisol concentration and serum levels of IL-$1{\beta}$ and IL-6 after Oligonol intake were significantly decreased compared to before treatment (P < 0.01, respectively). In addition, the rate of increase of these factors after exercise was decreased compared to the placebo group. There was no change in the WBC and differential cell counts. These results suggest that oral Oligonol intake for four weeks had a significant effect on inhibition of inflammatory markers in healthy young men.

• Journal of Nutrition and Health
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• 제32권2호
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• pp.158-165
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• 1999

Effects of oral taurine supplementation (6g/day) on plasma concentration and urinary of free amino acids were evaluated in healthy female adults. Among twenty five female volunteers(23.6$\pm$0.3 years old) participated in the taurine supplementation program, twenty four subjects successfully completed the two supplementation program. Plasma and urinary levels of free amino acids were determined by using an automated amino acid analyzer based on ion-exchange chromatography. Two weeks of taurine supplementation resulted in a 65% increase in plasma taurine concentration (p<0.001), Changes in fasting plasma amino acid concentrations followed by taurine supplementation were not spectacular, and were all within the normal range for human aldults. Taurine supplementation significantly elevated urinary methionine, asparagine, hydorxyproline and phosphoserine excretions(31~280%), and significantly decreased the urinary excretions of isoleucine, glutamate and serine compared to the values prior to taurine supplementation. For almost every individual amino acids, 24 hr urinary excretion level was significantly correlated to the urinary excretion value expressed as nmol/mg creatinine(p<0.001). A significant negative correlation found between plasma glutamine concentration and urinary glutamine excretion level suggests that the decrease in plasma glutamine concentration might be associated with the enhanced glutamine excretion in urine followed by taurine supplementation.

• 대한한방부인과학회지
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• 제28권1호
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• pp.58-72
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• 2015

Objectives: The purpose of this study was to examine the effects of fermented soybean on body weight, body fat, serum lipid profiles in obese women, especially specific to menopausal woman. Methods: Sixty healthy obese volunteers who visited ${\bigcirc}{\bigcirc}$ University Oriental Hospital from May 20th, 2014 to September 25th, 2014 took part in clinical trial. They divided into 2 groups, 30 volunteers allocated to fermented soybean and other 30 to placebo group. Body weight, BMI, waist and hip ratio, serum lipid were measured 3 times, and fat percentage, leptin, adiponectin were evaluated 2 times. Results: All 60 volunteers completed 12-week trial. 5 men were excluded, and 2 women against the clinical decision rule were excluded. In the end, 53 women were studied as clinical subjects. After 12 weeks intervention, there was no effects in comparison of group by time interaction. Without considering time interaction, there was a significant difference in triglyceride level between soybean group and placebo group (p=0.044). Treatment group were dividing by age 40, a group in age 40 or over 40, and other group aged below 40. There was a significant difference in group by time interaction of total cholesterol level, and without considering time interaction, there was a significant change in waist-hip ratio between groups. Conclusions: There were no effects on weight and body fat decrease in 12-week trial using fermented soybean as a supplement. But there were significant differences in triglyceride change between the treatment and placebo groups, also cholesterol and waist and hip ratio in soybean group divided by age 40. It seems that fermented soybean is effected on improving serum lipid profiles.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 2002년도 창립10주년기념 및 국립독성연구원 의약품동등성평가부서 신설기념 국재학술대회:생물학적 동등성과 의약품 개발 전략을 위한 국제심포지움
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• pp.205-205
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• 2002

Two formulations of tiropramide {(${\pm}$)${\alpha}$-(benzoylamino)-4-[2-(diethylamino)-ethoxy]-N,N-dipropyl-benzenepropanamide hydrochloride}, an antispasmodic agent, were orally administered to 16 healthy Korean male volunteers by Latin crossover design with the purpose of evaluating bioeqivalence and phamacokinetics of tiropramide. Tiropramide in human plasma was determined by a gas chromatography/nitrogen phosphorus detector. Detection limit of tiropramide was 5 ng/ml. C$\_$max/ values in test and reference formulations were 93.9 ${\pm}$ 54.3 and 96.4 ${\pm}$ 51.6 ng/ml, respectively. AUC$\_$0\longrightarrowlast/ and AUC$\_$0\longrightarrowinf/ were, respectively, 330.7 ${\pm}$ 193.9 and 349.5 ${\pm}$ 205.3 ng.hr/ml for test formulation, 348.9 ${\pm}$ 207.7 and 380.8 ${\pm}$ 239.0 ng.hr/ml for reference formulation. Terminal half-life was 2.3-2.6 hr. Bioavailability differences for C/aub max/ and AUC$\_$0\longrightarrowlast/ were 2.48% and 5.22%, respectively. Minimum detection differences were less than 20% in both C$\_$max/ AUC. Based on this results, two formulations of tiropramide were considered to be bioequivalent