The bioequivalence and pharmacokinetics of alendronate sodium tablets were examined by determining the plasma concentration of alendronate. Two groups, consisting of 24 healthy volunteers, each received a 70 mg reference alendronate sodium tablet and a test tablet in a $2{\times}2$ crossover study. There was a 6-day washout period between doses. The plasma alendronate concentration was monitored for 7 h after the dose, using HPLC-Fluorescence Detector (FD). The area under the plasma concentration-time curve from time 0 to the last sampling time at 7 h $(AUC_{0-7h})$ was calculated using the linear-log trapezoidal rule. The maximum plasma drug concentration $(C_{max})$ and the time to reach $C_{max}(T_{max})$ were derived from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_{0-7h}\;and\;C_{max}$, and untransformed $T_{max}$. For the test medication versus the reference medication, the $AUC_{0-7h}\;were\;87.63{\pm}29.27\;vs.\;102.44{\pm}69.96ng\;h\;mL^{-1}$ and the $C_{max}$ values were $34.29{\pm}13.77\;vs.\;38.47{\pm}24.39ng\;mL^{-1}$ respectively. The $90\%$ confidence intervals of the mean differences of the logarithmic transformed $AUC_{0-7h}$ and $C_{max}$ values were log 0.8234-log 1.1597 and log 0.8222-log 1.1409, respectively, satisfying the bioequivalence criteria guidelines of both the US Food and Drug Administration and the Korea Food and Drug Administration. The other pharmacokinetic parameters for the test drug versus reference drug, respectively, were: $t_{1/2},\;1.87{\pm}0.62\;vs.\;1.77{\pm}0.54\;h;\;V/F,\;2061.30{\pm}986.49\;vs.\;2576.45{\pm}1826.05\;L;\;CL/F,\;835.32{\pm}357.35\;vs.\;889.48{\pm}485.87\;L\;h^{-1}; K_{el},\;0.42{\pm}0.14\;vs.\;0.40{\pm}0.18\;h^{-1};\;Ka,\;4.46{\pm}3.63\;vs.\;3.80{\pm}3.64\;h^{-1};\;and\;T_{lag},\;0.19{\pm}0.09\;vs.\;0.18{\pm}0.06\;h$. These results indicated that two alendronate formulations(70-mg alendronate sodium) were biologically equivalent and can be prescribed interchangeably.
Journal of the Korean Applied Science and Technology
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v.35
no.4
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pp.1185-1196
/
2018
The purpose of this study was to investigate the effects of 12-week aquarobics exercise on blood lipids, atherogenic index, and liver functions in elderly women. The subjects for the study were 25 healthy elderly women volunteers, aged 65 to 80 years, composed of the aquarobics exercise group (n=13) and control group (n=12). Twice a week for 60 minutes for 12 weeks. The exercise intensity was set to RPE 11-12 for 1 week to 4 weeks, RPE 13-14 for 5 week to 8 weeks and RPE 15-16 for 9 week to 12 weeks respectively. The test data were analyzed by two-way repeated measures ANOVA, paired t-test, and independent t-test. The alpha level of .05 was set for all tests of significance. The results of the study in the aquarobics exercise group were as follows; LDL-C (p<.05), AST (p<.05) had significantly decreased, with TC (p<.01), TG (p<.05), LDL-C (p<.05), LDL-C/HDL-C (p<.05), TG/HDL-C (p<.05), AST (p<.001) significantly lower than control group. Consequently, these findings suggest that regular aquarobics exercise will be effective for preventiy the metabolic syndrome and cardiovascular health in elderly women.
Ha, Soo-Min;Kim, Jung-Sook;Kim, Ji-Hyeon;Kim, Do-Yeon
Journal of the Korean Applied Science and Technology
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v.35
no.4
/
pp.1096-1107
/
2018
The purpose of this study was to investigate the effects of combined exercise on blood inflammatory factors, DHEA-s and arterial stiffness in elderly women. The subjects were 42 elderly females volunteers, aged 70 to 85 years, composed of the combined exercise group (n=21) and control group (n=21). The 60 minute combined exercise program(aquarobics 1 time/week, strength exercise 2 times/week) was performed 3 times per week for 12 weeks, and the intensity was progressively increased every 4 weeks(1-4 weeks: RPE 12 to 13, 5-8 weeks: RPE 13 to 14, 9-12weeks: RPE 14 to 15). The test data were analyzed by two-way repeated measures ANOVA, paired t-test, independent t-test and the alpha level of .05 was set for all tests of significance. As a result, the combined exercise for 12 weeks reduced the inflammatory response of elderly women, and DHEA-s was found to have a positive effect on aging hormone. The arterial stiffness decreased the central arterial blood pressure (systolic and diastolic), prevented the increase of the pulse pressure and the wave increase index, and decreased the pulse wave velocity. These results suggest that regular and continuous combined exercise may be recommended for the healthy aging and longevity of elderly women by inducing anti-inflammation effect and improving the aging hormonal function and the vascular health.
Journal of the Society of Cosmetic Scientists of Korea
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v.44
no.4
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pp.455-463
/
2018
Skin elasticity has been known to be influenced by the change of dermal components such as collagen, elastic fiber, and glycosaminoglycans. However, it is unclear whether the uppermost epidermis may affect the mechanical characteristics of elasticity. In present study we tried to find the role of stratum corneum when determining the elastic property under skin bioengineering measurement with $Cutometer^{(R)}$. A total of 10 healthy volunteers aged 25-40 years were investigated by the parameters reflecting the skin elasticity from face and volar forearm. Within various ranges of suction pressure, R0 (=Uf), R7 (=Ur/Uf) and R8 (=Ua) were obtained to explore the depth-associated elasticity. In addition, these parameters were re-measured after the skin was fully hydrated. As results, we found that the measurement of depth-associated elasticity was possible as using various suction pressure. And the R7 parameter was significantly lower from face than those from forearm in before hydration (p < 0.05). Also, we found that the hydration of stratum corneum could affect skin elasticity. Especially, the R7 parameter at 300 mbar suction pressure of face skin showed significantly increased values than that of before hydration (p < 0.05). Interestingly, measured data from the face before and after hydration manifested relatively higher variation than from the forearm. These results suggest that it is possible to evaluate the skin elasticity considering the changes of stratum corneum and epidermis by using various suction pressure and skin hydration.
Gorantla, Vasavi R.;Bond, Vernon Jr.;Dorsey, James;Tedesco, Sarah;Kaur, Tanisha;Simpson, Matthew;Pemminati, Sudhakar;Millis, Richard M.
Journal of Pharmacopuncture
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v.22
no.3
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pp.166-170
/
2019
Objectives: Attentional and memory functions are important aspects of neural plasticity that, theoretically, should be amenable to pharmacopuncture treatments. A previous study from our laboratory suggested that quantitative electroencephalographic (qEEG) measurements of theta/beta ratio (TBR), an index of attentional control, may be indicative of academic performance in a first-semester medical school course. The present study expands our prior report by extracting and analyzing data on frontal theta and beta asymmetries. We test the hypothesis that the amount of frontal theta and beta asymmetries (fTA, fBA), are correlated with TBR and academic performance, thereby providing novel targets for pharmacopuncture treatments to improve cognitive performance. Methods: Ten healthy male volunteers were subjected to 5-10 min of qEEG measurements under eyes-closed conditions. The qEEG measurements were performed 3 days before each of first two block examinations in anatomy-physiology, separated by five weeks. Amplitudes of the theta and beta waveforms, expressed in ${\mu}V$, were used to compute TBR, fTA and fBA. Significance of changes in theta and beta EEG wave amplitude was assessed by ANOVA with post-hoc t-testing. Correlations between TBR, fTA, fBA and the raw examination scores were evaluated by Pearson's product-moment coefficients and linear regression analysis. Results: fTA and fBA were found to be negatively correlated with TBR (P<0.03, P<0.05, respectively) and were positively correlated with the second examination score (P<0.03, P=0.1, respectively). Conclusion: Smaller fTA and fBA were associated with lower academic performance in the second of two first-semester medical school anatomy-physiology block examination. Future studies should determine whether these qEEG metrics are useful for monitoring changes associated with the brain's cognitive adaptations to academic challenges, for predicting academic performance and for targeting phamacopuncture treatments to improve cognitive performance.
Jeon, Kyung Soo;Yang, Hee Seung;Jang, Soo Woong;Shin, Hee Dong;Lee, Yun kyung;Lee, Young;Lee, Seul Bin Na;Ahn, Dong Young;Sim, Woo Sob;Cho, Min;Cho, Kyu Jik;Park, Dong Beom;Park, Kwan Soo
Clinical Pain
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v.19
no.2
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pp.70-79
/
2020
Objective: We evaluated the efficacy of a newly-developed spinal orthoses (V-LSO) by comparing the stabilizing effect, abdominal pressure, and comfort of 3 different semirigid LSOs (classic LSO, V-LSO, and Cybertech®) during various body movements. Method: Thirty healthy volunteers (23~47 years, 24 males, 6 females) were selected. A dual inclinometer measured the range of motion (ROM) while the participants performed flexion/extension and lateral flexion of the lumbar spine with 3 LSOs. The LSO's pressure on the abdominal surface was measured using 9 pressure sensors while lying, sitting, standing, flexion/extension, lateral flexion, axial rotation, and lifting a box. Comfort and subjective immobilization were analyzed by a questionnaire. Results: V-LSO had a statistically significant effect on flexion over Cybertech®. No significant differences were noted during extension and lateral flexion between the 3 LSOs. The abdominal pressure showed no significant differences while supine. While sitting, standing, and lifting a box, the mean abdominal pressure for V-LSO were significantly higher than those for Cybertech®. During lumbar flexion, the mean abdominal pressures for classic LSO and V-LSO were significantly higher than that of Cybertech®. For extension, lateral flexion and axial rotation, the abdominal pressure for V-LSO was significantly higher than those of classic LSO and Cybertech®. In the subjective analysis, V-LSO and Cybertech® scored best for comfort. Conclusion: The V-LSO and Cybertech® were more comfortable than the classic LSO, and hence, may have improved compliance with decreased discomfort. V-LSO may be superior to the other LSOs in restricting lumbar movement and increasing intraabdominal pressure.
Jin-hyun Yang;Gyo-hyeon Lee;Kyung-ho Park;Soo-kyoung Park
The Journal of Korean Academy of Orthopedic Manual Physical Therapy
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v.29
no.1
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pp.41-52
/
2023
Background: Bulgarian split squat (BSS) is beneficial to improve dynamic balance ability and muscle activity of lower extremities, however its effects have not been fully investigated. Therefore, this study aimed to compare changes in dynamic balance ability and muscle properties according to various modifications of BSS exercises. Methods: Thirty healthy male volunteers participated in this study, and they were randomly divided into three different groups. The subjects performed the BSS exercise either on a stable surface with the eyes opened (n=10) or eyes closed (n=10), and on an unstable support plane with eyes opened (n=10) conditions, respectively. Dynamic balance ability was measured via Biodex balance system under the eyes-opened and closed conditions. Additionally, muscle properties of the rectus femoris (RF), vastus medialis (VM) and vastus lateralis (VL) were evaluated. Results: Dynamic balance ability did not show the significant differences among the groups that performed the BSS exercises. However, in the Unstable group, there were significant differences in the overall stability index and anterior posterior stability index under the eyes-closed condition between pre-exercise and post-exercise. In comparison of muscle properties according to the groups, RF muscle showed a significant difference in amount of change of elasticity (p=.038). Additionally, there were significant changes in post measurements of VM muscle tone (p=.016), stiffness (p=.012) and elasticity (p=.002). VL muscle, however had no significant differences in muscle properties. Conclusion: These results indicate that BSS exercises could induce the alteration of RF and VM muscle properties, in particular VM muscle which is susceptible to weakness. Thus, BSS could be applied in various ways as an effective rehabilitation exercise.
Yeom, Hyesun;Lee, Tae Ho;Youm, Jeong-Rok;Song, Jin-Ho;Han, Sang Beom
Analytical Science and Technology
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v.22
no.1
/
pp.101-108
/
2009
The bioequivalence of two pioglitazone tablets, Actos$^{(R)}$ tablet (Takeda Chemical Industries, reference drug) and Pioglitazone tablet (Boryung Company, test drug) was evaluated according to the guidelines of Korea Food and Drug Administration. Twenty-eight healthy male Korean volunteers received each medicine (pioglitazone dose of 30 mg) in a $2{\times}2$ crossover study with one week washout interval. After drug administration, blood samples were collected at specific time intervals from 0-36 hours. The plasma concentrations of pioglitazone were determined by high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The total chromatographic run time was 5 min and calibration curves were linear over the concentration range of 5-2000 ng/mL for pioglitazone. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The primary calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two preparations. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Pioglitazone tablet and Actos$^{(R)}$ tablet were log0.9422~log1.1040 and log0.9200~log1.1556, respectively. Based on the statistical considerations, we can conclude that the test drug, Pioglitazone tablet was bioequivalent to the reference drug, Actos$^{(R)}$ tablet.
Kim, Jin Hee;Park, Ah Yeon;Jung, Eun Ha;Lee, Cheol Woo;Lee, Tae Ho;Youm, Jeong-Rok
Analytical Science and Technology
/
v.20
no.4
/
pp.323-330
/
2007
A simple and rapid HPLC method with fluorescence detection(FLD) for quantitation of penciclovir in human plasma using a monolithic column was developed and validated. Penciclovir and ganciclovir(internal standard, I.S.) were separated on a Chromolith column RP-18e ($4.6{\times}100mm$) with a mobile phase consisting of a mixture of (A) methanol/50 mM sodium phosphate buffer containing 200 mg/L sodium dodecyl sulfate (3/97, pH 2.5) and (B) methanol/50 mM sodium phosphate buffer containing 200 mg/L sodium dodecyl sulfate (50/50, pH 2.5) at a flow gradient of $1.6{\sim}4.0mL/min$. The retention times of penciclovir and internal standard were less than 4.0 min. Calibration curve was linear ($R^2=0.9994$) over a concentration range of $0.1{\sim}5{\mu}g/mL$. Intra-day precision, accuracy and inter-day precision were 1.36~8.55 %, 92.8~100.0 % and 0.93~5.62 %, respectively with a limit of quantitation at $0.1{\mu}g/mL$. The present HPLC-FLD method is sensitive, precise and accurate. The method described herein has been successfully used for the bioequivalence study of a famciclovir formulation product after oral administration to healthy Korean volunteers.
Journal of Korea Entertainment Industry Association
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v.13
no.8
/
pp.435-446
/
2019
The purpose of this study was to investigate the effect of strength exercise program(60 minutes/day, 3 times/week) on health-related fitness and the factor of metabolic syndrome in the older at senior care facilities during 12 weeks. Twenty-seven volunteers were recruited for the study and divided into two groups: 15 persons(82.6yrs) undertook a continuous 12 weeks strength exercise program(EG), and 12 persons(78.9yrs) served as a control group(CG). The data process of this study calculated as mean(M) and standard Deviation(SD) of all measured value, used repeated measure ANOVA, and paired t-test. The significant level of hypothesis verification is set-up as α=.05. After 12 weeks in EG, health-related fitness increased by an average of 15.2% for right grip strength(p<.05), 26.9% for left grip strength(p<.05), 32.7% for chair stand(p<.05), 92.5% for one leg stand(p<.05), 29.6% for sit and reach(p<.05), and 34.5% for TUG(p<.05); CG showed no difference between pre and post. In the factor of metabolic syndrome, Systolic BP(3.1mmHg) and fasting blood glucose(7.4mg/dl) decreased in the EG group(p<.05). In summary, the strength exercise program leads to a genuine increase in health-related fitness and decrease in the factor of metabolic syndrome in the older adults. The well planned strength exercise seems to be an important intervention to improve function fitness in this population.
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