• Journal of Pharmaceutical Investigation
• /
• v.34 no.4
• /
• pp.319-325
• /
• 2004

A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac 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 24 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 $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
• /
• v.34 no.6
• /
• pp.505-511
• /
• 2004

A bioequivalence study of $Bestidine^{TM}$ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A $Gaster^{TM}$ (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 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 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 crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the Cmax ratio for $Bestidine^{TM}/Gaster^{TM}$ were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Bestidine^{TM}$ and $Gaster^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
• /
• v.34 no.6
• /
• pp.521-527
• /
• 2004

Cimetidine is a histamine $H_2-receptor$ antagonist, used for the treatment of endoscopically or radiographically comfirmed duodenal ulcer, pathologic GI hypersecretory conditions, and active, benign and gastric ulcer. Simple method for determining cimetidine in human plasma has been developed and validated. The analytical procedure for cimetidine showed a linear relationship in the concentration ranges from $0.05\;to\;5\;{\mu}g/ml$. Coefficient of variance (CV, %) for intraday and interday validation and relative error (RE, %) were less than ${\pm}15%$. Based on this analytical method, the bioequivalence of two cimetidine 400 mg tablets, reference (Tagamet 400 mg) and test drug (Sinil CIMETIDINE 400 mg) was evaluated according to the guidelines set by the Korea Food and Drug Administration (KFDA). Release of cimetidine from the tablets in vitro was tested using KP VIII Apparatus II with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). Twenty-four healthy volunteers, $21.38{\pm}1.86$ years in age and $68.71{\pm}8.68\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 400 mg of cimetidine, blood samples were taken at predetermined time intervals and concentrations of cimetidine in plasma were determined using HPLC equipped with UV detector. The dissolution profiles of the two tablet formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as $AUC_t$ and $C_{max}$ were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in $AUC_t$ and $C_{max}$ between the two tablets were 4.17 % and 0.97% respectively. At 90% confidence intervals, the differences in these parameters were also within ${\pm}20%$. All of the above mentioned parameters have met the criteria of KFDA guidelines for bioequivalence, indicating that the test drug tablet (Sinil CIMETIDINE tablet) is bioequivalent to Tagamet 400 mg tablet.

• Journal of Pharmaceutical Investigation
• /
• v.37 no.6
• /
• pp.397-402
• /
• 2007

To evaluate the bioequivalence of two venlafaxine formulations, a standard 2-way randomized cross-over study was conducted in twenty-four healthy male Korean volunteers. A single oral dose of 75 mg of test formulation Venfaxine $OR^{(R)}$ (tablet) or reference formulation Efexor $XR^{(R)}$ (capsule) was administered with one-week washout period. Plasma concentrations of venlafaxine were assayed for over a period of 72 hours with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS). The $mean{\pm}S.D$. of maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $64.7{\pm}28.5$ ng/mL, $9.2{\pm}3.0$ h, and $67.2{\pm}30.2$ ng/mL, $9.9{\pm}3.5$ h for test and reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ expressed in median value (range), for the test and the reference, were 10 h (6-14) and 8h (4-12), respectively. Similarly, area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$, for test and reference formulations were $1185{\pm}755$, $1326{\pm}896$ and $1124{\pm}737$, $1185{\pm}755$ $ng{\cdot}h/mL$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log transformed values of $AUC_t$, and $C_{max}$ were 0.9630 to 1.1383 and 0.8650 to 1.0446, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribe interchangeably.

• Journal of Pharmaceutical Investigation
• /
• v.38 no.2
• /
• pp.135-142
• /
• 2008

The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom 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 crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

• Journal of Biosystems Engineering
• /
• v.34 no.2
• /
• pp.127-132
• /
• 2009

In the working population, muscle fatigue and musculoskeletal discomfort are common, which, in the case of insufficient recovery may lead to musculoskeletal pain. Workers suffering from musculoskeletal pains need to be rehabilitated for recovery. Isokinetic testing has been used in physical strengthening, rehabilitation and post-operative orthopedic surgery. Frequency analysis of electromyography (EMG) signals using the mean frequency (MNF) has been widely used to characterize muscle fatigue. During isokinetic contractions, EMG signals present strong nonstationarities. Hilbert-Haung transform (HHT) and autoregressive (AR) model have been known more suitable than Fourier or wavelet transform for nonstationary signals. Moreover, several analyses have been performed within each active phase during isokinetic contractions. Thus, the aims of this study were i) to determine which one was better suitable for the analysis of MNF between HHT and AR model during repetitive maximum isokinetic extensions and ii) to investigate whether the analysis could be repeated for sequential fixed epoch lengths. Seven healthy volunteers (five males and two females) performed isokinetic knee extensions at $60^{\circ}/s$ and $240^{\circ}/s$ until 50% of the maximum peak torque was reached. Surface EMG signals were recorded from the rectus femoris of the right thigh. An algorithm detecting the onset and offset of EMG signals was applied to extract each active phase of the muscle. Following the results, slopes from the least-square error linear regression of MNF values showed that muscle fatigue of all subjects occurred. The AR model is better suited than HHT for estimating MNF from nonstationary EMG signals during isokinetic knee extensions. Moreover, the linear regression can be extracted from MNF values calculated by sequential fixed epoch lengths (p> 0.0I).

• Korean Journal of Acupuncture
• /
• v.26 no.2
• /
• pp.15-25
• /
• 2009

Objective: This paper aimed to understand influences on EEG conducting acupuncture stimulation, by comparing the changes in the acupoints on the body before and after normal people are treated with acupuncture at PC9 and TE3, which are referred to as Wood points(木穴), and PC5 and TE1, which are referred to as the Metal points(金穴) among the five shu points of Yin pericardium Meridian and Yang Triple Energizer Meridian. Methods: The study was performed on 30 healthy female volunteers in their 20's. EEG was measured for 5 minutes before acupuncture stimulation was conducted on PC9, TE3, PC5 and TE1. During 20 minutes of acupuncture treatment, the same items were continuously measured to find out whether there were any changes in them, and they were measured for 5 minutes after removing the acupuncture needles in order to implement a comparative analysis. Results: Comparision of EEG data before and after the treatment at PC9 shows no significant differences in all wave. Compared with the pre-acupuncture period at TE3, $\delta-\theta$ wave decreased significantly (P<0.05) during the acupuncture stimulation periods. Compared with the pre-acupuncture period at PC5, $\delta-\theta$ wave and high $\alpha$ wave increased significantly (P<0.05) during the acupuncture stimulation periods. And Mid $\beta$ wave and high $\beta$ wave decreased significantly (P<0.05) during the acupuncture periods and the post acupuncture periods. Compared with the Pre-acupuncture period at TE1, $\delta-\theta$ wave, $\theta$ wave and high $\alpha$ wave increased significantly (P<0.05) during the acupuncture stimulation periods. And Low $\beta$ wave decreased significantly (P<0.05) during the acupuncture periods. Conclusion: When acupuncture stimulation was performed on PC9 and TE3, referred to as the "Wood points", brain waves were stabled, while when acupuncture was performed on PC5 and TE1, called the "Metal points", a brain was waked. From the findings of this study, we hypothesize that the wood properties, from which growing starts in all things, are related with fast waves of EEG, and the metal properties, which stabilize and converge in all things, are related with slow waves of EEG.

• The Journal of the Korea Contents Association
• /
• v.9 no.9
• /
• pp.278-286
• /
• 2009

The aims of this study were to determined whether excitability of the $\alpha$-motor neuron is modulated by stretching and this changes were associated with flexibility of the muscle. In this study, $\alpha$-motor neuron excitability was measured by using the Hmax/Mmax ratio of the gastrocnemius H-reflex, and muscle flexibility was measured with the range of motion of the ankle dorsiflexion. The gastrocnemii of 10 healthy volunteers were stretched for 4 minutes(2 minutes stretching, 1 minute rest, and 2 minutes stretching) in each session by manual force. The Hmax/Mmax ratio of the H-reflex, as well as the range of motion of the ankle dosiflexion was measured through four different conditions: before stretching, as soon as after $1^{st}$ stretching, as soon as after $2^{nd}$ stretching and at 48 hours after $2^{nd}$ stretching. Excitability of the $\alpha$-motor neuron was decreased significantly after $1^{st}$ and $2^{nd}$ stretching(p<0.05). Furthermore, the range of the dorsiflexion was increased significantly after $1^{st}$ and $2^{nd}$ stretching(p<0.05). However, the excitability of the $\alpha$-motor neuron and range of the dorsiflexion at 48 hours after $2^{nd}$ stretching were not different from those of before stretching. These results suggest that reduced $\alpha$-motor neuron excitability of the gastrocnemius and increased flexibility of the ankle dorsiflexion would be followed by activation of the type III mechanoreceptor which around the ankle joint and the Golgi tendon organ in the gastrocnemius.

• Journal of Korean Medicine Rehabilitation
• /
• v.29 no.4
• /
• pp.81-88
• /
• 2019

Objectives This study is a preliminary study for safe and accurate cervical Hyeopcheok acupuncture by comparing the depth of cervical Hyeopcheok acupoint with cervical spine rotation. Methods Researchers took ultrasonographic images of cervical Hyeopcheok acupoint during full rotation of cervical spine, 45 degree rotation and neutral condition in a prone position. 4 healthy volunteers were recruited. Results No significant difference in needling depth of cervical Hyeopcheok acupoint was observed. However, there were a differences in anatomical structures' shape such as muscles. Conclusions There are no significant difference in needling depth, but anatomical structures' shape were changed. This result mean that if patient rotate cervical spine during acupuncture treatment, it can occur complications. Thus, when acupuncture treatment on cervical Hyeopcheok acupoint, practioner should make subject's cervical spine alignment corrected and be careful not to change posture during the procedure.

• Journal of the Society of Cosmetic Scientists of Korea
• /
• v.41 no.4
• /
• pp.413-420
• /
• 2015

The skin is one of the largest organs in our body and participates in many of the human organism's physiological and pathological events. Skin function were known for self-maintenance and self-repair, mechanical and chemical stress protection, protection against UV and environmental pathogenic micro-organisms, production of vitamin D, and social and psychological function through the physical aspect. The aim of this study was to evaluate the variation of biophysical parameters and to find relation with skin biomarkers in different anatomical site and age in Korean women. About 70 healthy volunteers in age range 20 to 49 were participated in this test. Test areas were the forearms and the cheek. Investigation to determine biophysical parameters on human skin, was carried out using various non-invasive methods. For analysis to skin biomarkers, we studied to examine various biomarkers for the quantitative determination of cortisol, fibronectin, keratin-1, 10, and 11, involucrin, and keratin-6 in human face and forearm. And we measured to skin biophysical parameters for skin anatomical site and age difference with non-invasive methods. As results of measuring site, some parameters were have following significant difference, stratum corneum hydration, trans epidermal water loss and skin color (L and a value). As results of age difference, skin colors were had only significant difference with age. For cortisol, keratin-6, fibronectin, keratin-1, 10, 11 contents, there were no significant difference in age and site. However, involucrin level in the cheeks were the highest for age group 30 ~ 39 compared to other age groups. These results suggest that in individual skin condition may explain detailed skin state variation.