• Journal of Pharmaceutical Investigation
• /
• v.36 no.2
• /
• pp.143-148
• /
• 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
• /
• v.36 no.1
• /
• pp.67-73
• /
• 2006

Lornoxicam is a nonsteroidal anti-inflammatory drug that decreases prostaglandin synthesis by inhibiting cyclooxygenase. It has analgesic, antipyretic and antiinflammatory effects. The purpose of the present study was to evaluate the bioequivalence of two lornoxicam tablets, $Xefo^{\circledR}$ (Hyundai Pharmaceutical Ind. Co., Ltd.) and Lornocam (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of lornoxicam from the two lornoxicam 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 eight healthy male subjects, $24.39{\pm}1.95$ years in age and $68.63{\pm}7.25$ kg in body weight, were divided into two groups and a randomized $2\;{\time}\;2$ cross-over study was employed. After a single tablet containing 4 mg as lornoxicam was orally administered, blood samples were taken at predetermined time intervals and the concentrations of lornoxicam 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, $Xefo^{\circledR},$ were -1.56%, 2.16% and -17.12% 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 0.8 to log 1.25 (e.g., $log\;0.90{\sim}log\;1.05$ and $log\; 0.88{\sim}log\;1.17$ for $AUC_t\;and\;C_{max},$ respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Lornocam tablet was bioequivalent to $Xefo^{\circledR}$ tablet.

• Journal of Pharmaceutical Investigation
• /
• v.39 no.1
• /
• pp.65-71
• /
• 2009

The aim of the present study was to evaluate the bioequivalence of two domperidone maleate tablets, Motilium-$M^{(R)}$ Tablet (Janssen Korea Ltd., reference product) and $Toriem^{(R)}$ Tablet (Daewon Pharm. Co., Ltd., test product). Domperidone was extracted by liquid-liquid extraction using tert-butyl methyl ether and separated in less than 3 min on $C_{18}$ reverse-phase column using an isocratic elution. 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 $426.1{\rightarrow}119.1$ and the m/z $837.4{\rightarrow}158.2$ transitions for domperidone and the internal standard (roxithromycin), respectively. Calibration curves, from $0.05{\sim}50$ ng/mL of domperidone, showed correlation coefficients (r) higher than 0.9941. Intra day and inter day precision (C.V. %) for quality control were ranged from 10.04 to 16.09% and from 10.87 to 18.69%, respectively. The lower limit of quantification (LLOQ) of domperidone was 0.05 ng/mL. The method described is precise and sensitive and has been successfully applied to the study of bioequivalence of domperidone in 24 healthy Korean volunteers. Twenty-four healthy male Korean volunteers received a single dose of each medicine ($2{\times}12.72\;mg$ domperidone maleate) in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of domperidone were monitored for over a period of 24 hr after the administration. $AUC_{0-t}$ (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 within acceptable range of log 0.8 to log 1.25 (e.g., $log\;0.92{\sim}log\;1.05$ for $AUC_{0-t}$, $log\;0.81{\sim}log\;1.05$ for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that $Toriem^{(R)}$ tablet is bioequivalent to Motilium-$M^{(R)}$ tablet.

• Exercise Science
• /
• v.21 no.2
• /
• pp.183-190
• /
• 2012

This study is to evaluate the availability of cardiorespiratory fitness measurement by 20 m shuttle run test based upon energy contribution rates of elite athletes in different sports type. Sixty-seven elite athletes attending K national university participated in this study. They were divided by three groups based upon sports type, composed of Anaerobic Group (sprint, jumps, weightlifting, throw; n=35), Aerobic Group (medium-long distance; n=9), and Combat Sport Group (judo; n=23). 20 m shuttle run test was conducted by Leger et al.(1982) method and calculating acceleration using measured shuttle run repetitions was conducted by Brewer et al.(1988) method. To test the usefulness of VO₂max, graded exercise treadmill test was conducted and standing long jump and 50 m run were measured as power fitness factors. Z-jump was used for measuring power, agility, and muscular endurance. Standing long jump and 50 m run of Anaerobic Group (AnG) was significantly higher than that of Aerobic Group (AeG) and Combat Sport Group (CG) (p<0.05). However, Z-jump of CG was significantly higher than that of AnG and AeG(p<.05). There was a higher correlation of 20 m shuttle run test and VO₂max in AnG(r= 0.577, p<.0001) and CG(r= 0.760, p<.0001). Otherwise, there was a low correlation of 20 m shuttle run test and VO₂max in AeG. There was no significant group difference to test the availability of 20 m shuttle run test and there was a reduced error when converting 20 m shuttle run results into VO₂max. This study examined the usefulness of 20 m shuttle run test by converting 20 m shuttle run repetition results into VO₂max calculation, which showed reduced error. Therefore, this study confirmed that it would be needed to convert 20 m shuttle run results into VO₂max for universal and practical use in the field without dividing sports type.

• Archives of Pharmacal Research
• /
• v.18 no.4
• /
• pp.237-242
• /
• 1995

For the vioequivalence study of two ceftriaxone injection formulations ($Rocephin{\circledR}$ ; Roche, and Triaxone ; Hanmi0, the HPLC analytical method for the analysis of ceftriaxone in plasma was used. Fourteen healthy volunteers completed the study and each subject were IM in jected signle doses (1 g) of the test and the reference formulations in a two-way crossover design with an one week drug free interval between doses. Following each administration, plasma concentrations of ceftrixone were monitored over a period of 24 h. Bioequivalence parameters $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT determined from the data obtained for the two formulations were examined by analyses of variance (ANOVA) and other criteria and tests for bioequivalence. Results of ANOVA and confidence limits of test/reference ratios of $AUC_{24th}, {\;}T_{max}, {\;}C_{max}$ and MRT, and statistical tests indicated the bioequivalence of the two formulations (i.e., test/reference ratio was within $100{\pm}20%$) except for $T_{max}$ The mean of $T_{max}$ showed only 6. 9% difference from the reference but the detection limit was 22.5% which is slightly over the 20% criteria. No pharmacokinetic parameters including Ka, Kel, Vd and Cl indicated significant difference in between the two fomulations. It was concluded that the data yielded fro the two cefriaxone formulations demonstrated that they were bioequivalent.

• Transactions on Electrical and Electronic Materials
• /
• v.18 no.6
• /
• pp.359-363
• /
• 2017

A slotted implantable patch antenna with microstrip feeding is proposed for industrial, scientific, and medical band applications. The result is verified by implanting the antenna in animal tissue. Further, by varying the ground width and introducing a defect into the ground structure, the antenna becomes applicable for worldwide interoperability for microwave access operations. A simulation is performed using Empire XCcel software. An Agilent vector network analyzer is used for analyzing the return loss performance. Simulated and measured results are compared. Antennas with and without defected ground structure both have key advantages including low profile, desirable return loss, good impedance matching and required bandwidth.

• The Magazine of the Society of Air-Conditioning and Refrigerating Engineers of Korea
• /
• v.17 no.4
• /
• pp.328-335
• /
• 1988

Natural convection in annuli between the horizontal and vertical concentric cylinders for ratio of the inner to the outer radius, $R_1$=0.85, 0.35 has been studied by the numerical analysis. Governing equations are numerically sloved by means of Successive over-relaxation methods. It is found that maximum local Nusselt number, $Nu_{1.max}$ at the inner cylinder and $Nu_{2.max}$ at the outer cylinder for $R_2$=0.35 have maxima at ${\phi}=0^{\circ}$, ${\phi}=180^{\circ}$ ${\xi}=0.4$, 1.6 for horizontal cylinder and at bottom, top for vertical cylinder, respectively. In the present study, mean Nusselt numbers at the vertical cylinder increased more than that at the horizontal cylinder by about 64% for $R_1$=0.35.

• Nonlinear Functional Analysis and Applications
• /
• v.27 no.3
• /
• pp.691-700
• /
• 2022

Let p(z) be a polynomial of degree n having no zero inside the unit circle. Then for 0 < r ≤ 1, the well-known inequality due to Rivlin [Amer. Math. Monthly., 67 (1960) 251-253] is $$\max\limits_{{\mid}z{\mid}=r}{\mid}p(z){\mid}{\geq}{\(\frac{r+1}{2}\)^n}\max\limits_{{\mid}z{\mid}=1}{\mid}p(z){\mid}$$. In this paper, we generalize as well as sharpen the above inequality. Also our results not only generalize, but also sharpen some known results proved recently.

• Biomolecules & Therapeutics
• /
• v.11 no.2
• /
• pp.145-150
• /
• 2003

The bioequivalence of two tablet formulations of 12.72mg domperidone maleate (Sinil "$Perinal^{\circledR}$" tablets vs. Janssen Korea "Motilium-$M^{\circledR}$" tablets) was assessed in healthy Korean volunteers after oral administration in a randomized crossover study. Blood samples were collected at spccified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of $AUC_{0{\rightarrow}48},\; C_{max},\;T_{max}$ and $t_{1/2}$ were determined from plasma concentration-time profile of two formulations. Any significant statistical differences were not observed between these two formulations. On the evaluation of bioequivalence according to Korea Food and Drug Administration Guideline, 90％ confidence limits after logmithmic transformation fell within the acceptable range (log 0.8∼log 1.25). Based on these data, it can be concluded that two domperidone maleate tablets showed comparable pharmacokinetic profiles, which means that the Sinil "$Perinal^{\circledR}$" tablet is bioequivalent to the Janssen Korea ""Motilium-M$^{\circledR}$".

• Proceedings of the Korean Society of Applied Pharmacology
• /
• 2002.07a
• /
• pp.206-206
• /
• 2002

The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ vs. Wyeth Korea $\textrm{Ledercoat}^{(R)}$) was assesed in healthy male Korean volunteers after oral administration of 16 mh triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0{\longrightarrow}last}$. $AUC_{0{\longrightarrow}imf}$, and $T_{1/2,\beta}$ were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to the United State or Korea Food and Drug Administration Guidelines. The analysis of variance did not show any signigicant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ tablet is bioequivalent to the $\textrm{Ledercoat}^{(R)}$ tablet produced by Wyeth Korea.