• Journal of Pharmaceutical Investigation
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• 제37권3호
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• pp.197-203
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• 2007

A bioequivalence study of $Dilast^{TM}$ Capsule (Chong Kun Dang Pharma. Co., Ltd.) to $Ketas^{(R)}$ Capsule (Han Dok Pharma. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty eight healthy male Korean volunteers received each medicine at the ibudilast dose of 20 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of ibudilast were monitored by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 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 $C_{max}$ ratio for $Dilast^{TM}$ $Capsule/Ketas^{(R)}$ Capsule were $log0.93{\sim}log1.06$ and $log0.93{\sim}log1.11$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Dilast^{TM}$ Capsule and $Ketas^{(R)}$ Capsule with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제35권4호
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• pp.303-308
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• 2005

The purpose of the present study was to evaluate the bioequivalence of two talniflumate tablets, SOMALGEN tablet (Kun Wha Pharm. Co., Ltd., Seoul, Korea, reference drug) and FLUTAL tablet (Kukje Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the talniflumate dose of 740 mg in a $2{\pm}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of niflumic acid were monitored by an HPLC-UV for over a period of 14 hr after the administration. $AUC_t$(the area under the plasma concentration-time curve from time zero to 14 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 $AUC_t$, $C_{max}$ and untransformed $T_{max}$. 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 SOMALGEN/FLUTAL were $log0.8510{\sim}log1.0318$ and $log0.9264{\sim}log1.0607$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Taken together, our study demonstrated the bioequivalence of SOMALGEN and FLUTAL with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제36권3호
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• pp.193-199
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• 2006

A bioequivalence study of $Sudo^{TM}$ Ranitidine HCI tablet (Sudo Pharma. Ind. Co., Ltd.) to $Curan^{TM}$ tablet (Il Dong Pharma. Ind. 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 ranitidine hydrochloride dose of 150 mg in a 2x2 crossover study. There was a one week wash-out period between the doses. Plasma concentrations of ranitidine were monitored by a high-turbulent liquid chromatography (HTLC) for over a period of 12 hours after drug 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 far 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 $Sudo^{TM}$ Ranitidine $HCl/Curan^{TM}$ were 0.92-1.00 and 0.90-1.03, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Sudo^{TM}$ Ranitidine HCI and $Curan^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제36권2호
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• pp.131-136
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• 2006

The purpose of the present study was to evaluate the bioequivalence of two losartan tablets, $Cozaar^{TM}$ tablet (MSD Korea. Co., Ltd., Seoul, Korea, reference drug) and $Losartan^{TM}$ tablet (DaeWon Pharm. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets at the losartan kalium dose of 100 mg in a $2\;{\time}\;2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of losartan were monitored by an LC-MS/MS for over a period of 12 hr 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 $C_{max}$ ratio for $Cozaar^{TM}/Losartan^{TM}$ were $log\;0.97{\sim}log\;1.12\;and\;log\;0.93{\sim}log\;1.23$, respectively. These values were within the acceptable bioequivalence intervals of $log\;0.80{\sim}log\;1.25$. Taken together, our study demonstrated the bioequivalence of $Cozaar^{TM}$ and $Losartan^TM$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제37권4호
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• pp.255-261
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• 2007

A bioequivalence study of $Nimegen^{TM}$ soft capsule (Medica Korea Pharma. Co., Ltd.) to $RoAccutane^{(R)}$ soft capsule (Roche Korea Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Thirty healthy male Korean volunteers received each medicine at the isotretinoin dose of 60 mg in a $2{\times}2$ crossover study. There was one week wash-out period between the doses. Plasma concentrations of isotretinoin were monitored by a high performance liquid chromatography (HPLC) for over a period of 48 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48 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 $C_{MAX}$ ratio for $Nimegen^{TM}/RoAccutane^{(R)}$ were $log0.860{\sim}log0.98\;and\;log0.85{\sim}log1.00$, respectively. These values were within the acceptable bioequivalence intervals of $log0.80{\sim}log1.25$. Thus, our study demonstrated the bioequivalence of $Nimegen^{TM}\;and\;RoAccutane^{(R)}$ with respect to the rate and extent of absorption.

• Journal of Oral Medicine and Pain
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• 제36권4호
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• pp.245-252
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• 2011

전통적으로 항구취 제제로 널리 쓰여 온 세틸피리디늄 및 염화아연이 함유된 양치액은 장기간의 사용에도 부작용이 없이 구취를 효과적으로 감소시키는 것으로 알려져 있다. 본 연구에서는 세틸피리디늄 및 염화아연을 주성분으로 한 구강 양치액의 아침 구취에 대한 효과를 관찰하고자 했다. 총 8명의 건강한 남자를 대상으로 crossover study를 진행했으며 1주일의 washout 기간을 두었다. 대상자들에게는 30초간 실험 용액 10 mL를 양치하게 했으며 1주일 후에 같은 방법으로 증류수를 양치하게 했다. 구취의 측정은 오전 8:30 분에 이루어졌으며 양치 전, 양치 후 1시간, 2시간, 3시간에 평가를 하였다. 구취의 평가는 관능구취검사와 이동성 황화합물 측정기(Halimeter)를 이용하였다. 세틸피리디늄과 염화아연을 함유한 구강 양치액은 양치 후 3시간까지 아침 구취를 감소시켰다. 관능구취검사 수치와 휘발성 황화합물의 농도는 실험군에서 시간에 따라 유의한 감소를 보였고 그 감소 양상은 두 군 간에 유의한 차이를 보였다. 결론적으로, 세틸피리디늄과 염화아연을 함유한 구강 양치액은 건강한 대상자의 아침 구취를 3시간까지 유의하게 감소시킬 수 있어 구취제거를 위한 양치액으로 그 효용성이 매우 크다.

• Journal of Pharmaceutical Investigation
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• 제34권6호
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• pp.505-511
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• 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
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• 제39권2호
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• pp.111-115
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• 2009

The pharmacokinetics of cyclosporin A (CsA) after single and multiple oral dosing of new CsA self-micro-emulsifying drug delivery system (SMEDDS) in dogs were estimated. A single dose study was performed following a two-way crossover design against six dogs with reference SMEDDS. For a multiple dose study, three dogs were allocated for each drug, and 100 mg of drug was administered daily for 6 days. Whole blood concentration of CsA was analyzed by radio-immunoassay. Both drug showed identical blood concentration profiles in both studies, and no statistical difference was detected in pharmacokinetic parameters. The relative bioavailabilities of test SMEDDS were 91.4% and 89.1%, respectively, in the single dose study and the last day of multiple dose study. Especially, multiple dose study proved the good relationship between C-0/C-2 and AUC for reference SMEDDS, which is an indispensable part of therapeutic drug monitoring. These results suggest newly formulated CsA SMEDDS possibly shows identical pharmacokinetics and pharmacodynamic behaviors in clinical trials.

• 지식경영연구
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• 제10권3호
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• pp.35-49
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• 2009

The purpose of this study is to examine whether suppliers are able to benefit by means of constructing a relationship-specific intangible asset and participating in collaboration with purchasers to actively maintain value created while mutually using inter-organizational information systems. To achieve the purpose of this study. 82 questionnaires have been analyzed from suppliers which are using electronic transactions through inter-organizational information systems. As a result, business process specificity and domain knowledge specificity, which are relationship-specific intangible assets, affect operational collaboration and strategic collaboration, which are classified by level of decision-making. Although both types of collaboration are needed to achieve both strategic and operational benefits, we find each collaboration to be uniquely promoted by a specific types of relationship-specific intangible asset. Operational collaboration is found to be an antecedent to operational benefit and strategic collaboration is found to be an antecedent to strategic benefits. No crossover between collaboration and supplier's benefits is found. Consequently, the result of this study shows collaboration is needed for domestic suppliers, which have relatively low levels of collaboration, to keep maintain relationship-specific intangible assets and to prevent the relationship termination cost when transactions have been stopped between supplier and purchaser. Also the results imply the supplier can have advantages by participating in collaboration.

• 농촌지도와개발
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• 제28권2호
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• pp.85-98
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• 2021

This study aims to examine consumer types based on pet food selection attributes and to analyze the differences in consumer characteristics by those types. In this study, the researcher uses k-means cluster analysis and crossover analysis to determine market segmention, and then analyzes the resultant characteristics by categorizing consumers. A total of 202 cases are used for this study. First, the selection attributes are classified into the six factors of credibility, quality, design, convenience, information, and price. Second, the clusters are categorized into the four clusters, which are designated pet food lower-involvement type, pet food information- and price-seeking type, pet food convenience-seeking type, and pet food higher-involvement type. Third, these four groups exhibit statistically significant differences in terms of occupational variables, number of pets, and purchase frequency. The results of this study may provide helpful information in establishing customized, market-based marketing strategies based on the characteristics of pet food consumers.