• 한국임상약학회지
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• 제12권1호
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• pp.22-28
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• 2002

Aceclofenac, 2-[(2',6'-dichlorphenyl)amino]phenylacetoxiacetic acid, is a new nonsteroidal anti-inflammatory drug that belongs to the family of phenylacetic acids. It shows good tolerance and potent analgesic/antiinflammatory properties, and acts on cartilaginous chondriocytes, stimulating their repair mechanism. The purpose of the present study was to evaluate the bioequivalence of two aceclofenac products, $Airtal^{TM}$ tablet (Daewoong Pharmaceutical Co.) and $Acer^{TM}$ capsule (Kyungdong Pharmaceutical Co.), according to the guideliner of Korea Food and Drug Administration (KFDA). The aceclofenac release from the two aceclofenac products in vitro was tested using KP VII Apparatus II method at pH 7.8 dissolution media. Sixteen normal male volunteers, $23.13\pm2.03$ years in age and $66.33\pm7.08$ kg in body weight, were divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet or capsule containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentrations of aceclofenac in serum were determined using HPLC with UV detector. The dissolution profiles of the two aceclofenac products were very similar at pH 7.8 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. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two products were $6.50\%,\;-1.06\%\;and\;11.96\%$ respectively, when calculated against the $Airtal^{TM}$ tablet. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;were\;89.82\%\;and\;82.84\%$, respectively. Minimum detectable differences $(\Delta)\;at\;\alpha=0.05\;and\;1-\beta=0.8$ were less than $20\%\;(e.g.,\;17.51\%\;and\;19.30\%\;for\;AUC_t,\;C_{max}$, ). The $90\%$ confidence intervals were within $\pm20\%\;(e.g.,\;-3.73\%\sim16.73\%\;and\;-12.34\%\sim10.22\%\;for\;AUC_t,\;C_{max},\;respectively)$. Two parameters met the criteria of KFDA for bioequivalence, indicating that $Acer^{TM}$ capsule is bioequivalent to $Airtal^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• 제23권1호
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• pp.41-49
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• 1993

The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was $Rosec^{\circledR}$ capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study ($2\;{\times}\;2$ Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) $(AUC_{0-8hr})$ $(1946.5{\pm}675.3\;vs\;2018.3{\pm}761.6\;ng{\cdot}hr/ml)$, AUC from time zero to infinite $(AUC_{o-\infty})$ $(2288.6{\pm}1212.8\;vs\;2264.9{\pm}1001.3\;ng{\cdot}hr/ml)$, maximum plasma concentration $(C_{max})$ $(772.5{\pm}283.3\;vs\;925.8{\pm}187.7\;ng/ml)$, time to maximum plasma concentration $(T_{max})$ $(2.38{\pm}1.06\;vs\;2.34{\pm}1.09\;hr)$, apparent elimination rate constant $(k_{\ell})$ $(0.5339{\pm}0.2687\;vs\;0.5769 {\pm}0.2184\;hr^{-I})$, apparent absorption rate constant $(k_a)$ $(1.1536{\pm}0.5278\;vs\;0.9739{\pm}0.9507 hr^{-1})$ and mean residence time (MRT) $(3.13{\pm}0.73\;vs \;3.41{\pm}1.04\;hr)$. The differences of mean $(AUC_{0-8hr})$, $C_{max}$, $T_{max}$ and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power $(1-{\beta})$ and treatment difference $(\triangle)$ for $AUC_{o-8hr}$ $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of $Rosec^{\circledR}$ capsule. Therefore, two products are bioequivalent based on the current results.

• Journal of Pharmaceutical Investigation
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• 제34권2호
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• pp.139-145
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd.) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperidone release from the two risperidone formulations in vitro was tested using KP VIII Apparatus II method with various of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33\;{\pm}2.10$ years in age and $69.24{\pm}8.05\;kg$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross over study was employed. After one tablet containing 2 mg as risperidone was orally administered, blood was taken at predetermined time intervals and the concentrations of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$,$C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the 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 Risperdal were 0.20, -1.29 and -11-09% for $AUC_t$,$C_{max},\;and\;T_{max}$, respectively There were no sequence effects two formulations in parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,$log(0.90){\sim}log(1.30)$ and $log(0.84){\sim}log(1.09)$ for$AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.

• Journal of Pharmaceutical Investigation
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• 제34권2호
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• pp.147-153
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two glimepiride tablets, $Amaryl^{\circledR}$ (Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn II Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, $22.65{\pm}2.19$ years in age and $66.55{\pm}8.85$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 2 mg as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, 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 Amaryl were -3.70, -8.28 and 0.61% 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., $log(0.84){\sim}log(1.04)$ for $log(0.82){\sim}log(1.03)$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.

• 약학회지
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• 제52권3호
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• pp.195-200
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• 2008

Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin 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, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, 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, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% 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 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

• 약학회지
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• 제52권3호
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• pp.188-194
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• 2008

Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic 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, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% 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 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.

• 한국작물학회지
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• 제43권2호
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• pp.105-112
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• 1998

Seeds of medicinal soybean [Glycine max(L.) Merill] are characterized by a black seed coat, white stripe at hilum border, yellow cotyledon, and very small seed weight. Production of this medicinal soybean has recently increased as a consumption increased. The objective of this study was to evaluate the growth characteristics and seed yield of collected medicinal soybeans and to obtain basic information on production practices and breeding materials. The collected medicinal soybean lines were cultivated at three locations for two years. Twenty-seven lines were planted at the Research Farm, Korea University, Namyangju city, on May 23, and at the Research Farm, Kyungpook National University, Taegu, on May 20, 1995. In 1996 field experiments, forty-four lines were planted on May 25, at Research Farm, Korea University, and twenty-seven lines among those were planted on June 7 at the Research Farm of National Yeongnam Agricultural Experiment Station, Milyang city. The investigated lines had purple or white flower. Flowering and maturing dates were similar or later than those of the control cultivars. Branch number was greater for the investigated lines. One hundred-seed weight of the lines ranged from 8.5 to 15.0 g. Mean seed yields ranged from 1.54 to 2.89 MT/ha. Nine lines of the investigated medicinal soybeans showed higher yield capacity than the control cultivars. Further research should be done on the improvement of the production system and breeding program of medicinal soybeans.

• 한국항해항만학회:학술대회논문집
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• 한국항해항만학회 1998년도 춘계학술발표회 논문집
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• pp.163-185
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• 1998

The purpose of this study was to analyze the physiology changes by circuit weight training(CWT). The subject of this study consists of 16 student on ship(experimental groups(SE) N=8, control group(SCa) N=8) and 16 students on land (experimental groups(LE) n=8, control groups(LCb) N=8). The items of measurement were the changes of CWT time and heart rate per week, musclear functino and cardiopulmonary function. The conclusions are as follows : 1. Muscular fuction 1) Back strength in SE and LE group was increased significantly (p<.01, p<.05, 8.86% and 7.08%).Grip strength was increased slightly in 4 groups but there was no significance. 2) In push-ups, all 4 groups were increased significantly (p<.05, p<.01), sit-ups also were increased significantly in SE and LE group (p<.05, 6.71% and 9.62%). 3) In SE and LE group , standing long jump was in significantly (p<.01, p<.05, 4.49% and 6.09%), but only in LE group , side step was increased significantly (p<0.1, 5.84%). 2. Cardiopulmonary function 1) HRrest was decreased slightly in all 4 groups but was not significant changes. HRmax was increased only in LE group significantly (p<.05, 2.81%), treadmill running time was increased significantly in SE and LE group respectively (p<.01, p<.05, 10.78% and 11.07%). 2) VEmax was increased significantly in SE and LE group(p<.05, p<.01, 10.59% and 13.68%), but only in LE group Rfmax was increased significantly (p<.01, 4.83%). 3) In VO2max, LCb group was increased significantly (p<.05, 6.835), but SCa group was decreased significantly (p<.05, 4.32). VO2max/kg$.$min was increased significantly in LE and LCb group respectively (p<.01 p<.05. 4.75% and 3.98%).

• 한국작물학회지
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• 제29권1호
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• pp.50-54
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• 1984

하대두형 품종에 대하여 파종기를 달리하고 비닐멀칭을 했을 때 생육 및 수량에 미치는 영향을 규명코져 다마미도리 지두를 4월 13일부터 10일 간격으로 4파종기로 하고, 비닐로 멀칭과 무멀칭으로 하여 시험한 결과를 요약하면 다음과 같다. 1. 출현기는 멀칭을 할 경우 무멀칭에 비하여 촉진되어 4월 13일 파종구는 11일 축진되었다. 개화일수도 멀칭을 할 경우 평균 6일이 단축되었고, 4월 13일 파종구는 12일이 단축되었다. 2. 멀칭구는 무멀칭에 비하여 주경장이 컸으며, 주경절수 및 분지수도 많았을 뿐 아니라. l0a당 건경중도 많았다. 평균 100립중은 차가 없었다. 멀칭의 경우 늦게 파종한 구에서 주경장이 컸고, 주경절수 및 분지수도 많았을 뿐 아니라 건경중도 높았으며, 100립중도 무거웠다. 이러한 현상은 일찍 파종한구에서 미이라병의 리병입률이 높았기 때문이다. 무멀칭의 경우는 멀칭구와 같은 경향을 보이지는 않았다. 3. 멀칭구에서 미이라병의 리병입율이 높으면 자반병 리병입율은 낮아졌다. 무멀칭구는 멀칭구에서와 같은 경향은 보이지 않았다. 4. 멀칭구에서는 무멀칭구보다 평균 20％가 증수되었고, 파종기별로 보면 일찍 파종한 구에서 미이라병에 대한 리병정도가 심하여 수량이 낮았고, 늦게 파종한 구에서 수량이 높았다.

• 한국작물학회지
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• 제51권4호
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• pp.310-317
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• 2006

This study was conducted to investigate the influence of drought stress during the pod developing and seed filling stage on source-sink relationships of soybean (Glycine max). Drought treatments were imposed by withholding water at the full-pod stage, 19 days after flowering, and then limited watering was relieved at 15 days after the initiation of drought treatment. Soybean seed yield was reduced by 39% mainly due to decreased pod number under drought stress, but the 100-seed weight was relatively less reduced. In spite of the 15-day drought during the full-pod stage, soybean produced good seeds showing similar l00-seed weight, protein, starch and soluble sugar content to those from the well-watered. Although drought during the full-pod stage caused source limitations; i.e. accelerated leaf senescence and reduced leaf soluble sugars, it did not cause limitations of other source characteristics such as SGR and leaf starch level. This is because the reduction in size of sinks, such as pod and seed abortions compensated for source limitations, resulting in balanced source-sink as expressed by LAR and the ratio of leaf area to seed dry weight. Drought stress during the pod developing and seed filling stage did not disrupt the source-sink balance