• Journal of Ginseng Research
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• v.33 no.2
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• pp.115-126
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• 2009

To evaluate the efficacy and safety of red ginseng on women's health-related quality of life (QOL) and sexual function. A randomized, double-blind, placebo-controlled, crossover clinical study was performed. The main efficacy was measured using the Female Sexual Function Index (FSFl) and the 36-Item Short-Form Health Survey (SF-36). Twenty-four healthy, married women aged 30-45 years with FSFl scores below 25 were randomly divided into two groups: the red-ginseng group (N=12) and the placebo group (N=12). During the first six-week period (Study 1), each group was given red ginseng or placebo twice a day. Before the start of the second six-week period (Study 2), a crossover design was chosen with a two-week break (washout period). Interchanging the two groups after the washout period, red ginseng and placebo were given to each group. The outcomes were measured before and after each six-week period. Overall, 23 participants completed the study. In Study 1, the changes relative to the baseline in the FSFl total score were 22.50% and 22.99% for red ginseng and placebo, respectively. In Study 2, the relative changes were 8.14% for red ginseng and 6.29% for placebo. The results showed a greater improving trend in Study 1 with respect to all of the participants' sexual functions, but no significant difference was found between the groups (P=0.9567). After taking red ginseng, all the participants exhibited an improving trend in the desire domain of FSFl, but no significant difference was shown. In the measurement of SF-36, no significant difference was likewise shown. After taking red ginseng, though, all the participants exhibited an improving trend in the physical functioning (PF) domain of SF-36, with no significant difference. Moreover, there was no significant adverse event related to red ginseng. The QOL and sexual function of the study participants in the red-ginseng group were mostly improved, but no statistically significant effect of red ginseng was shown. It is supposed that this result was partly due to the affirmative impression of red ginseng in Korea. Thus, it is anticipated that a long-term clinical trial will show a significant effect of red ginseng on the QOL and sexual function.

• Archives of design research
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• v.18 no.1 s.59
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• pp.167-174
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• 2005

This study is to objectively support the emotional and intuitional decision making of the designer by means of developing the supporting models and tools of color coordination. Based on the color grouping system and representative vocabularies suggested in the precedent 'Study on the Grouping System of Fabric Color,' this study suggested the manufacture of the supporting model of color coordination that could be used practically through the design of coloring group. The results of this study can be summarized as below. Firstly, 687 colors in total have been collected from the four world famous collections, the street fashion of 2002 F/W 2003 S/S Season and the representative brands in each group for five years from 1999 to 2003 in order to single out the basic colors for the purpose of composing the color groups. Secondly, 687 collected colors have been grouped into 144 colors in total through the three-step process for the extraction of coloring groups. Thirdly, the final extracted colors have been divided into , , , group by the grouping system specified in the precedent study and the said four large groups have been again subdivided into 12 small groups. Fourthly, the suggested colors in each group have established a color coordination system by introducing the concept of the crossover coordination that could be matched with other groups as well as the coordination within the group. Fifthly, we have dyed 144 colors in total that have consisted of the coloring system of four representative groups (twelve subgroups) in each methodical tone as in the above in cotton yarn, one of the representative materials in fabric fashion design industry. Besides, we have specified the symbol of the Pantone Color Book and CMYK values in each color that has consisted of the system considering the industrial characteristics of fashion as a global business and the compatibility with the related design industry. Sixthly, we have packed the completed yam made of fabrics in the designed container for the easy use of cross-coordination and have completed a color coordination system that could be easily utilized for the fashion-related working-level staffs.

• Journal of Pharmaceutical Investigation
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• v.39 no.3
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• pp.207-216
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• 2009

Fluconazole is used as an orally administrated antifungal drug for the treatment of tinea corporis, candidiasis including skin mycotic pneumonia infections. The dosage of fluconazole varies with indication ranging from 50 mg/day to 400 mg/day. The fluconazole capsule 50 mg (3 capsules daily) is already available in Korean market. To improve the patient compliance, a fluconazole tablet 150 mg (once a day administration) was developed recently. The purpose of this study was to evaluate the bioequivalence of three doses of fluconazole capsule 50 mg (Diflucan 50 mg, Pfizer Korea Inc., as a reference drug) and a single dose of fluconazole tablet 150 mg (Plunazol 150 mg, Daewoong Pharm. Co., Korea) according to the guidelines of the Korea Food and Drug Administration (KFDA). The bioequivalence for three capsules of Diflucan 50 mg and a single tablet of Plunazol 150 mg was investigated in twenty-four healthy male volunteers under a randomized 2${\times}$2 crossover trial design. The average age of twenty-four volunteers was 24.78${\pm}$3.27 year-old, average height was 175.56${\pm}$5.45 cm and average weight was 67.24${\pm}$6.86 kg. After three capsules of Diflucan 50 mg or a single tablet of Plunazol 150 mg were orally administered, blood was taken at predetermined time intervals and the plasma concentrations of fluconazole in plasma were determined using LC-MS-MS. The 90% confidence intervals for the main parameters of statistical results after logarithmic transformation were AUCt 0.9272-1.0084 and Cmax 0.8423-0.9544 respectively, which are in the range of log 0.8 to log 1.25 and the statistical results of additional parameters (AUClast, t1/2 and MRT) were also in the 90% confidence interval that is in the range of log 0.8 to log 1.25. Therefore, the results of this study confirm the bioequivalence of three capsules of Diflucan 50 mg to one tablet of Plunazol 150 mg.

• Asian-Australasian Journal of Animal Sciences
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• v.31 no.5
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• pp.677-685
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• 2018

Objective: The objective of the present study was to determine ammonium chloride tolerance of lactating dairy cows, by examining effects of negative dietary cation anion difference (DCAD) induced by ruminal ammonium chloride infusion on performance, serum and urine minerals, serum metabolites and enzymes of lactating dairy cows. Methods: Four primiparous lactating Chinese Holstein cows fitted with ruminal cannulas were infused with increasing amounts (0, 150, 300, or 450 g/d) of ammonium chloride in a crossover design. The DCAD of the base diet was 279 mEq/kg dry matter (DM) using the DCAD formula (Na + K - Cl - S)/kg of DM. Ammonium chloride infusion added the equivalent of 0, 128, 330, and 536 mEq/kg DM of Cl in treatments. According to the different dry matter intakes (DMI), the resulting actual DCAD of the four treatments was 279, 151, -51, and -257 mEq/kg DM, respectively. Results: DMI decreased linearly as DCAD decreased. Yields of milk, 4% fat-corrected milk, energy-corrected milk, milk fat, and milk protein decreased linearly as DCAD decreased. Concentrations of milk protein and milk urea nitrogen increased linearly with decreasing DCAD. Concentration of Cl- in serum increased linearly and concentration of PO43- in serum increased quadratically as DCAD decreased. Urine pH decreased linearly and calculated urine volume increased linearly with decreasing DCAD. Linear increases in daily urinary excretion of $Cl^-$, $Ca^{2+}$, $PO_4{^{3-}}$, urea N, and ammonium were observed as DCAD decreased. Activities of alanine aminotransferase, aspartate aminotransferase, and ${\gamma}-glutamyl$ transferase in serum and urea N concentration in serum increased linearly as DCAD decreased. Conclusion: In conclusion, negative DCAD induced by ruminal ammonium chloride infusion resulted in a metabolic acidosis, had a negative influence on performance, and increased serum enzymes indicating potential liver and kidney damage in lactating dairy cows. Daily ammonium chloride intake by lactating dairy cows should not exceed 300 g, and 150 g/d per cow may be better.

• Journal of Preventive Medicine and Public Health
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• v.49 no.4
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• pp.205-219
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• 2016

Objectives: No children-specified review and meta-analysis paper about the short-term effect of fine particulate matter ($PM_{2.5}$) on hospital admissions and emergency department visits for asthma has been published. We calculated more precise pooled effect estimates on this topic and evaluated the variation in effect size according to the differences in study characteristics not considered in previous studies. Methods: Two authors each independently searched PubMed and EMBASE for relevant studies in March, 2016. We conducted random effect meta-analyses and mixed-effect meta-regression analyses using retrieved summary effect estimates and 95% confidence intervals (CIs) and some characteristics of selected studies. The Egger's test and funnel plot were used to check publication bias. All analyses were done using R version 3.1.3. Results: We ultimately retrieved 26 time-series and case-crossover design studies about the short-term effect of $PM_{2.5}$ on children's hospital admissions and emergency department visits for asthma. In the primary meta-analysis, children's hospital admissions and emergency department visits for asthma were positively associated with a short-term $10{\mu}g/m^3$ increase in $PM_{2.5}$ (relative risk, 1.048; 95% CI, 1.028 to 1.067; $I^2=95.7%$). We also found different effect coefficients by region; the value in Asia was estimated to be lower than in North America or Europe. Conclusions: We strengthened the evidence on the short-term effect of $PM_{2.5}$ on children's hospital admissions and emergency department visits for asthma. Further studies from other regions outside North America and Europe regions are needed for more generalizable evidence.

• Korean Journal of Clinical Pharmacy
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• v.15 no.1
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• pp.21-26
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• 2005

A bioequivalence study of CKD $Cefaclor^{(R)}$ capsule (Chong Kun Dang Pharm Co., Ltd) to $Ceclor^{(R)}$ capsule (Lilly Korea Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the cefaclor dose of 250 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. An improved high-performance liquid chromatorgraphy (HPLC) analytical method with UV detection was used to determine plasma cefaclor concentration in human volunteers for 8 hr after oral drug administration. The area under the plasma concentration-time curve from time zero to 8 hr ($AUC_{0-8hr}$) was calculated by the linear trapezoidal rule. the $C_{max}$ (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 $AUC_{0-8hr}\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The $90{\%}$ confidence intervals of the $AUC_{0-8hr}$ ratio and the $C_{max}$ ratio for CKD $Cefaclor^{(R)}$ and $Ceclor^{(R)}$ were $0.9400{\leq}{\delta}{\leq}1.0345$ and $0.8858{\leq}{\delta}{\leq}1.1021$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the of CKD $cefaclor^{(R)}$ capsule was bioequivalent to $Cefaclor^{(R)}$ capsule with respect to its bioavailability.

• Journal of Pharmaceutical Investigation
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• v.35 no.2
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• pp.117-122
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• 2005

After establishing improved HPLC analytical method of cefaclor in human plasma samples, a bioavailability study of cefaclor capsules was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). The standard calibration curve using an HPLC with UV detector was constructed in a range of $0.0324{\sim}16\;{\mu}g/ml$. The 6% perchloric acid instead of 6% trichloroacetic acid was used to precipitate plasma protein. The HPLC chromatograms were precisely and accurately resolved when spiked with human plasma spiked with cefaclor and cephalexin (internal standard). Twenty healthy male Korean volunteers received two commercial cefaclor capsules, $Neocef^{\circledR}$ capsule (Jinyang Pharm. Co., Ltd) or $Ceclor^{\circledR}$ capsule (Lilly Korea. Co., Ltd.) at the 250 mg cefaclor in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of cefaclor were monitored for 8 hours after oral drug administration. $AUC_t$ the area under the plasma concentration-time curve from time zero to 8 hr (13 points), 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 cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Neocef^{\circledR}/Ceclor^{\circledR}$ were $0.9049{\leq}{\delta}{\leq}1.226$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Neocef^{\circledR}/Ceclor^{\circledR}$ with respect to the extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.34 no.5
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• pp.413-418
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• 2004

A bioequivalence of $Melax^{TM}$ capsules (Chong Kun Dang Pharm., Korea) and $Mobic^{TM}$ capsules (Boehringer Ingelheim Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 15 mg dose of meloxicam of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2\;{\times}\;2$ crossover design. Concentrations of meloxicam in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 72 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 performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Melax^{TM}/Mobic^{TM}$ were 0.95 - 1.04 and 0.98 - 1.14, respectively. This study demonstrated a bioequivalence of $Melax^{TM}$ and $Mobic^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.137-142
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• 2006

A bioequivalence of Daewoong $Alendronate^{TM}$ (Daewoong Pharmaceutical Co., Ltd., Korea) and $Fosamax^{TM}$ tablets (MSD Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). A single 70 mg dose of sodium alendronate of each medicine was administered orally to 56 healthy male volunteers. This study was performed in a $2\;{\time}\;2$ crossover design. Concentrations of alendronate in the urine were monitored by a high-performance liquid chromatography (HPLC). $A_{et}$ (cumulative urinary excreted amount from time 0 to last sampling interval) was calculated by the accumulation of the urinary excreted alendronate. $U_{max}$ (maximum urinary excretion rate) and $T_{max}$ (time to reach $U_{max}$) were compiled from the urinary excretion rate - time data. Analysis of variance was performed using logarithmically transformed $A_{et}$ and $U_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $A_{et}$ and $U_{max}$ for Daewoong $Alendronate^{TM}/Fosamax^{TM}$ were 0.89-1.12 and 0.82-1.02, respectively. This study demonstrated the bioequivalence of Daewoong $Alendronate^{TM}$ and $Fosamax^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.40 no.1
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• pp.63-66
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• 2010

The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.