• Korean Journal of Clinical Pharmacy
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• v.7 no.1
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• pp.17-21
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• 1997

Cefaclor is a second generation cephalosporin antibiotic that shows a potent antibacterial activity against both Gram-positive and Gram-negative bacteria, when it is orally administered. Due to its patent expiration, a number of generic drugs have been marketed, but not yet elucidated to ensure therapeutic equivalence. In this study, cefaclor capsules manufactured by Chong Kun Dang were bioequivallently assessed by comparing with $Ceclor^{TM}$ introduced originally by Daewoong Lilly. A total of 16 healthy male volunteers were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of cefaclor in plasma were measured upto 6 hours following a single oral administration of two capsules (500 mg of cefaclor) by high-performance liquid chromatography with UV detection. Although the plasma concentration at 6 hours was not detected, the computed half-life of cefaclor was approximately 0.5 hours. The area under the concentration-vs-time curve from 0 to 4 hours $(AUC_{0-4h})$ was calculated by the trapezoidal summation method. The differences in mean values of $AUC_{0-4h}$, peak plasma concentration $(C_{max})$, and time to peak concentration $(T_{max})$ between the two products were $4.63\%,\;1.84\%,\;and\3.28\%$, respectively. The least significant differences at $\alpha4= 0.05 for $AUC_{0-4h},\;C_{max},\;and\;T_{max}\;were\;6,53\%,\;4.05\%,\;and\;6.47\%$, respectively. In conclusion, the test drug was bioequivalent with the reference drug.

• Journal of Pharmaceutical Investigation
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• v.33 no.1
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• pp.51-53
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• 2003

This study was conducted to compare the bioavailability of a generic product of Sinil Atenolol Tablets (Sinil Pharmaceutical Co., Ltd., Korea) with the innovator product, $Tenormin^{\circledR}$ Tablets in 20 healthy Korean volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way crossover design. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs time curves, the following parameters were compared: area under the plasma concentration-time curve (AUC), peak plasma concentration $(C_{max})$, time to reach peak plasma concentration $(T_{max})$, and terminal first order elimination half-life $(t_{1/2})$. No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed AUC and $C_{max}$ values of the two products. The 90% confidence for the ratio of the logarithmically transformed AUC and $C_{max}$ values of Sinil Atenolol Tablets over those of $Tenormin^{\circledR}$ Tablets were calculated to be between 0.99 and 1.07, and 1.04 and 1.16, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ Tablet group was 3.68 hour, and that in Sinil Atenolol Tablet group was 3.65 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean $t_{1/2}$ values of $Tenormin^{\circledR}$ Tablets and Sinil Atenolol Tablets were 5.9 and 6.0 hour, respectively. Based on these results, it was concluded that Sinil Atenolol Tablets were comparable to $Tenormin^{\circledR}$ Tablets in both the rate and extent of absorption, indicating that Sinil Atenolol Tablets were bioequivalent to the reference product, $Tenormin^{\circledR}$ Tablets

• Biomolecules & Therapeutics
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• v.15 no.2
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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.

• International Journal of Vascular Biomedical Engineering
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• v.1 no.1
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• pp.32-40
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• 2003

Axillo-bifemoral (Ax-Fem) bypass are now well accepted for bilateral iliac artery occlusion as the second best option. This extra-anatomical (unnatural) bypasses, however, have various hemodynamic liabilities affecting the patency. Hemodynamic conditions of each different type of Ax-Fem bypass were assessed with computer simulation model to determine the hemodynamically more sound type. Simulation models of five different types of Ax-Fem bypass were constructed. Our investigation based on the computer simulation models have shown distinct differences between two most popular Lazy-S type and Inverted-C type on the distribution of flow volume, shear stress and recirculation zone, etc., though both types have shown similar clinical results. Lazy-S type has shown better hemodyanmic status than inverted-C type. The theoretical advantage of "Lazy-S" type has never been adequately proved for its superiority clinically over the inverted-C type. Inverted-C type is now in more favor with clinically better results in spite of many hemodynamic liabilities including retrograde flow to the branching graft. The improvement of over-all long-term patency rate of various extra-anatomical bypasses is still warranted through proper correction of the hemodynamic liability. Even though clinical outcome of the extra-anatomical bypass has been equal regardless of the type of crossover femoral graft configuration, there are distinct differences on the hemodynamic characteristics among various types of configuration. Further hemodynamic study in the pulsatile flow status is warranted to correct hemodynamic defects with proper modification of various hemodynamic factors of each model.

• Journal of Microbiology and Biotechnology
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• v.19 no.10
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• pp.1092-1097
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• 2009

A novel exopolysaccharide named Ebosin was produced by Streptomyces sp. 139, with medicinal activity. Its biosynthesis gene cluster (ste) has been previously identified. For the functional study of the ste7 gene in Ebosin biosynthesis, it was disrupted with a double crossover via homologous recombination. The monosaccharide composition of EPS-7m produced by the mutant strain Streptomyces sp. 139 ($ste7^-$) was found altered from that of Ebosin, with fucose decreasing remarkably. For biochemical characterization of Ste7, the ste7 gene was cloned and expressed in Escherichia coli BL21. With a continuous coupled spectrophotometric assay, Ste7 was demonstrated to have the ability of catalyzing the transfer of fucose specifically from GDP-$\beta$-L-fucose to a fucose acceptor, the lipid carrier located in the cytoplasmic membrane of Streptomyces sp. 139 ($ste7^-$). Therefore, the ste7 gene has been identified to code for a fucosyltransferase, which plays an essential role in the formation of repeating sugars units during Ebosin biosynthesis.

• Journal of Pharmaceutical Investigation
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• v.41 no.5
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• pp.309-315
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• 2011

A sensitive and specific liquid chromatographic method coupled with tandem mass spectrometry (LC-MS/MS) was developed for the analysis of ambroxol (active moiety of acebrophylline). After acetonitrile precipitation of proteins from plasma samples, ambroxol and the domperidone (internal standard, IS) were eluted on a C18 column. The isocratic mobile phase was consisted of 10 mM ammonium acetate and methanol (10 : 90, v/v), with flow rate at 0.2 mL/min. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z 379.2${\rightarrow}$264.0 and the m/z 426.2${\rightarrow}$175.1 transitions for ambroxol and the IS, respectively. Twenty four healthy Korean male subjects received two capsules (100 mg ${\times}$ 2) of either the test or the reference formulation of acebrophylline HCl in a 2 ${\times}$ 2 crossover study, this was followed by a 1week washout period between either formulation. $AUC_{0-t}$ (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. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 (e.g., log 0.8964 - log 0.9910 for $AUC_{0-t}$ log 0.8690 - log 1.0750 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of Korea Food and Drug Administration for bioequivalence indicating that Acephyll$^{(R)}$ capsule (test) is bioequivalent to Surfolase$^{(R)}$ capsule (reference).

• The Korean Journal of Physiology and Pharmacology
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• v.20 no.2
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• pp.193-200
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• 2016

Sertraline, a selective serotonin reuptake inhibitor (SSRI), has been reported to lead to cardiac toxicity even at therapeutic doses including sudden cardiac death and ventricular arrhythmia. And in a SSRI-independent manner, sertraline has been known to inhibit various voltage-dependent channels, which play an important role in regulation of cardiovascular system. In the present study, we investigated the action of sertraline on Kv1.5, which is one of cardiac ion channels. The effect of sertraline on the cloned neuronal rat Kv1.5 channels stably expressed in Chinese hamster ovary cells was investigated using the whole-cell patch-clamp technique. Sertraline reduced Kv1.5 whole-cell currents in a reversible concentration-dependent manner, with an $IC_{50}$ value and a Hill coefficient of $0.71{\mu}M$ and 1.29, respectively. Sertraline accelerated the decay rate of inactivation of Kv1.5 currents without modifying the kinetics of current activation. The inhibition increased steeply between -20 and 0 mV, which corresponded with the voltage range for channel opening. In the voltage range positive to +10 mV, inhibition displayed a weak voltage dependence, consistent with an electrical distance ${\delta}$ of 0.16. Sertraline slowed the deactivation time course, resulting in a tail crossover phenomenon when the tail currents, recorded in the presence and absence of sertraline, were superimposed. Inhibition of Kv1.5 by sertraline was use-dependent. The present results suggest that sertraline acts on Kv1.5 currents as an open-channel blocker.

• Korean Journal of Clinical Pharmacy
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• v.13 no.1
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• pp.13-17
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• 2003

This study was carried out to compare the bioavailability of $Ceclex^{(R)}$ SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor $MR^{(R)}$ SR IAB (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean volunteers. The bioavailability was examined on 24 healthy volunteers who received a single dose (375 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 7 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters $(AUC_{0-7h},\;C_{max},\;T_{max},\;AUC_{inf},\;K_e,\;t_{1/2},\;V_d/F,\;and\;CL/F)$ were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the $T_{max}$, log-transformed $AUC_{0-7h$}$, log-transformed $C_{max},\;t_{1/2},\;V_d/F$, and $CL/F$. The ratios of geometric means of $AUC_{0-7h}\;and\;C_{max}$ between test drug End reference drug were $95.67\%\;(8.55\;vs\;8.18{\mu}g{\cdot}hr/ml)\;and\;103.86\%\;(2.85\;vs\;2.96{\mu}g/ml)$, respectively. The $T_{max}$ of test drug and reference drug was $2.56\pm0.15\;and\;2.23\pm0.13\;hrs,\;respectively.\;The\;90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-7h}\;and\;C_{max}$ were log0.90-log1.04 and log0.91-log1.13, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug.

• Journal of Acupuncture Research
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• v.28 no.5
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• pp.57-64
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• 2011

Objectives : The purpose of this study is to compare the efficacy after acupuncture on local acupoints group and distal acupoints group for chronic neck pain. Design : A randomized, crossover clinical trial. Methods : From 15st, September 2010 to October 30th, 2010. 20 patients with chronic neck pain were randomly assigned to either group A or group B. Group A received acupuncture at local acupoints then after 1 week washout period acupuncture at distal acupoints. Group B received the treatment in reverse order. To evaluating efficiency and satisfaction, visual analog scale(VAS), neck disability index(NDI), cranio-cervical flextion test(C-CFT) and five-point likert scale were measured before and after each treatment. Results : Patients in local acupoints group experienced greater improvement than distal acupoints group in VAS. Both local acupoints group and distal acupoints group showed significant improvement in NDI but not in C-CFT and the NDI score change comparison between the two groups had no significance. Local acupoints group showed more effective than distal acupoints group on five-point likert scale. Conclusions : Local acupoints is more effective than distal acupoints in controlling pain in chronic neck pain.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.33 no.4A
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• pp.377-386
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• 2008

In this paper, a new handover management scheme has been proposed to reduce handover latency and to support fast handover without packet losses, so that it may be applicable to the wireless mobile Internet system such as IPv6-based WiBro system. To minimize the handover latency in processing of movement detection, we propose the handover management scheme which simplifies the handover message exchanging procedure between mobile subscriber station (MSS) and network by integrating layer 2 and layer 3 handovers efficiently based on the layer2 information. To reduce the processing delay from new care-of-address (NCoA) configuration during handover, we propose that NCoA is created, distributed and managed by new access control router (NACR). In addition, in order to minimize the packet transmission delay and eliminate the packet losses, the proposed scheme employs a crossover router (CR) which is upper network located over PACR and NACR and employs the packet buffering for MSS. The simulation study shows that the proposed scheme achieves loss-free packet delivery and low latency in the environment of narrow overlapped cell area or high velocity of the MSS, comparing the performance with the conventional schemes.