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Bioequivalence Test of Rebamipide 100 mg Tablets (레바미피드 100 mg 정제의 새울학적동등성)

  • Kim, Se-Mi;Cho, Hea-Young;Kang, Hyun-Ah;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.1
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    • pp.38-44
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    • 2008
  • Rebamipide, ($\pm$)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl] propionic acid, is used for mucosal protection, healing of gastroduodenal ulcers, and treatment of gastritis. It works by enhancing mucosal defense, scavenging free radicals and temporarily activating genes encoding cyclooxygenase-2. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{(R)}$ (Korea Otsuca Pharmaceuticals Co., Ltd.) and Mustar (Korean Drug Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of rebamipide from the two rebamipide formulations in vitro was tested using KP VIII Apparatus II method with pH 6.8 dissolution medium. Twenty six healthy male subjects, $23.46{\pm}2.63$ years in age and $66.62{\pm}8.97\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 100 mg as rebamipide was orally administered, blood samples were taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. 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, $Mucosta^{(R)}$ were -5.08, 3.52 and -9.71 % 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 1.07 and log 0.90$\sim$log 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Mustar tablet was bioequivalent to $Mucosta^{(R)}$ tablet.

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An Evaluation of Effectiveness for Providing Safety Navigation Supporting Service : Focused on CPA/TCPA Information Supplying Service (안전 항해 지원 서비스 제공에 대한 유용성 평가(II) : CPA/TCPA 정보 제공 서비스를 대상으로)

  • Hwang, Hun-Gyu;Kim, Bae-Sung;Shin, Il-Sik;Lee, Jang-Se;Yu, Yung-Ho
    • Journal of the Korea Institute of Information and Communication Engineering
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    • v.21 no.9
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    • pp.1788-1795
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    • 2017
  • In this paper, we proposed a service that provides CPA/TCPA information to ships, without ARPA/ATA devices to support decision making of the navigator for maritime safety based on various services at shore and off-shore. To verify the proposed service, we use SiNAS (scenario-based simulator for NAS) with CPA/TCPA information providing software to evaluate its usability, because executing the test in real ship has many limitations and difficulties. To do this, we specify two simulation scenarios for the required purpose, and we liaise twelve participants with various navigation experience to conduct the simulations. Also, we analyze the results of simulation using mission success or not, the minimum approaching distance with the target ship, the time of a recognition the target ship, the time of a first action for collision avoidance with the target ship, and so on. Then, we evaluate usability of the proposed service based on the three elements which are effectiveness, efficiency and satisfaction.

Effects of Chitosan on Cholesterol Level and Hepatic Morphology in Ethanol-treated Rats (키토산의 섭취가 에탄올을 급여한 흰쥐의 콜레스테롤농도 및 간조직 헝태에 미치는 영향)

  • Kim, Kil-Nam;Kim, Se-Kwon;Jeon, You-Jin
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.34 no.6
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    • pp.814-820
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    • 2005
  • This study was designed to determine the effect of chitosan on in vivo lipid metabolism in male Sprague-Dawley rats treated with ethanol. Rats were divided into four groups and reared for 6 weeks: E group ($35\%$ of total calories from ethanol), EC I group ($ethanol+0.5\%$ of chitosan), EC II group ($ethanol +1\%$ of chitosan) and control group (dextrin as much as ethanol treated). The levels of serum total cholesterol (TC) and LDL-cholesterol (LDL-C), GOT and GPT in plasma, and triglyceride (TG) in liver were remarkably increased in the rats treated with ethanol. However, the treatment of $1\%$ chitosan significantly lowered those parameter levels. In particular the values of r-HDL (the ratio of HDL-C to TC) in the rats fed in combination with ethanol and chitosan were relatively higher than that of the E group. The increased lipid droplets were observed in the hepatocytes of the rats treated with ethanol, but chitosan treatment reduced in the number and the size of the lipid droplets. These results suggest that chitosan improve in vivo lipid metabolism and Potentially protect hepatotoxicity of the rat liver treated with ethanol.

Cretaceous Epithermal Au-Ag Mineralization in the Muju-Yeongam District (Sulcheon Mineralized Area), Republic of Korea (한반도(韓半島) 무주(茂朱)-영암(靈岩)지역 백악기(白堊紀) 천열수(淺熱水) 금(金)-은(銀) 광화작용(鑛化作用) 연구(설천(雪川)지역 광화대(鑛化帶)))

  • So, Chil-Sup;Yun, Seong-Taek;Choi, Sang-Hoon;Kim, Se-Hyun;Kim, Moon-Young
    • Economic and Environmental Geology
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    • v.25 no.2
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    • pp.115-131
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    • 1992
  • Late Cretaceous (90.5 Ma), epithermal gold-silver vein mineralization of the Weolseong and Samchang mines in the Sulcheon area, 60 km southeast of Taejeon, can be separated into two distinct stages (I and II) during which fault-related fissures in Precambrian gneiss and Cretaceous (102 Ma) porphyritic granite were filled. Fluid inclusion and mineralogical data suggest that quartz-sulfide-electrum-argentite-forming stage I evolved from initial high temperatures $({\approx}340^{\circ}C})$ to later lower temperatures $({\approx}140^{\circ}C})$ at shallow depths of about 400 to 700 m. Ore fluid salinities were in the range between 0.2 and 6.6 wt. % eq. NaCl. A simple statistic model for fluid-fluid mixing indicates that the mixing ratio (the volumetric ratio between deep hydrothermal fluids and meteoric water) systematically decreased with time. Gold-silver deposition occurred at temperatures of $230{\pm}40^{\circ}C$ mainly as a result of progressive cooling of ore-forming fluids through mixing with less-evolved meteoric waters. Measured and calculated hydrogen and oxygen isotope values of hydrothermal fluids indicate meteoric water dominance, approaching unexchanged meteoric water values. The geologic, mineralogic, and geochemical data from the Weolseong and Samchang mines are similar to those from other Korean epithermal gold-silver vein deposits.

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Microstructure and Microdefects of Diamond Thin Films Deposited by MPECVD (마이크로웨이브 화학증착법에 의한 다이아몬드 박막의 미세구조오 미세결함)

  • Lee, Se-Hyeon;Lee, Yu-Gi;Park, Jong-Wan
    • Korean Journal of Materials Research
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    • v.6 no.8
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    • pp.833-840
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    • 1996
  • Diamond thin films were deposited on p-type (100) Si wafers using MPECVD. Prior to deposition, ultrasonic striking was done to improve density of nucleation sites with dimond powder of 40~$60\mu$m size. Then diamond thin films were deposited at $^900{\circ}C$, 40Torr and 1000W microwave power using ${CH}_{4}$ and ${H}_{2}$ gases. The purity, the morphology and the microstructur'e and microdefects of diamond thin films were characterized by Raman spectroscopy, SEM and TEM, repectively. In Raman spectroscopy the peaks of non-diamond phase increased as ${CH}_{4}$, concentration increased. In SEM, the morphology of diamond thin films varied from crystalline to cauliflower as ${CH}_{4}$, concentration increased. As ${CH}_{4}$ con centration increased, the density of defects increased, with most defects being {III} twin. ${MTP}_{5}$, were formed with five (II]) planes. As these (Ill) Planes were twinned, ${MTP}_{5}$, represented five-fold symmetry. ]n the interfaces, defects in diamond thin films fanned out from small regions implying nucleation sites.

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EFFECTS OF SURFACE TREATMENTS AND STORAGE CONDITIONS ON TARGIS/DENTIN BOND STRENGTH (Targis 표면처리가 상아질과의 전단결합강도에 미치는 영향)

  • Oh, Young-Taek;Hwang, Su-Jin;Lee, Se-Joon;Lee, Kwang-Won
    • Restorative Dentistry and Endodontics
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    • v.25 no.2
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    • pp.262-271
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    • 2000
  • The purpose of this study was to estimate shear bond strength according to difference in Targis surface treatment and storage condition. 140 non-carious extracted human molars and Targis D210(Ivoclar, Liechtenstein) were used in the present study and were divided into 7 experimental groups respectively according to surface treatment of Targis. Group 1 ; No treatment, Group 2 ; $50{\mu}m$ aluminium oxide blasting, Group 3 ; 4% HF etching for 3 minutes, Group 4 ; 4% HF etching after blasting, Group 5 ; silane treatment after blasting, Group 6 ; silane treatment after 4% HF etching, Group 7 ; silane treatment after blasting and 4% HF etching. In Each group, one half of 20 specimens was stored in distilled water at $37^{\circ}C$ for 24 hours and the other half was stored at atmosphere for 24 hours respectively. Dentin surface was etched with 10% $H_3PO_4$ for 15 seconds and luting cement(Variolink II, Vivadent, Liechtenstein) was applied by manufacturer's recommendation. Shear bond strength for each group was then measured. To examine the failure patterns after shear bond test and to observe the change after surface treatment of Targis. Specimens were fabricated and observed under the SEM. Statistical analysis was performed by One Way ANOVA test and t-test. The results were as follows ; 1. The shear bond strength of the groups stored in water significantly lower than that of groups stored at atmosphere (P<0.05). 2. There was no significant difference in shear bond strength in groups stored in water (P>0.05). 3. The shear bond strength without surface treatment of Targis were lowest among all experimental groups in atmosphere condition(P<0.05). 4. There was no significant difference in bond strength between groups using the silane or not(P>0.05). 5. The groups treated by blasting, hydrofluoric acid and silane sequentially showed highest bond strength than that of other groups in atmosphere condition, but there was no significant difference(P>0.05). 6 The proportions of the specimens showing the mixed fracture failure were 20% in HF etching group and blasting + HF group, 40% in blasting + HF + silane group in atmosphere condition. All the specimens stored in water showed adhesive fracture failure.

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Clinical Evaluation of Dose Distribution in High Dose Rate Intracavitary Irradiation in the Treatment of Cervical Cancer (고선량 강내 조사법을 이용한 자궁 경부암의 방사선 치료 계획에 대한 임상적 고찰)

  • Shin, Sei-One;Kim, Myung-Se
    • Journal of Yeungnam Medical Science
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    • v.6 no.1
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    • pp.87-98
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    • 1989
  • Clinical estimation of bladder and rectal doses from high dose rate intracavitary irradiation in carcinoma of the cervix uteri has been initiated on a routine basis in an effort to obtain the optimum radiotherapeutic dose. Simulation films with contrast media are used to image the bladder and rectum, and dose rates are estimated at various interesting points with the aid of treatment planning computer, NEC Therac-2300. Fifty-three patients have been reviewed in order to ascertain the correlation between radiation dose at interesting points in the bladder and rectum and the dose at Point A and B. The dose ratio between doses at Point A 'and interesting points is an important clinical factor in evaluating the treatment planning. This also serves as documentation of the dose to normal structures within the treatment volume. Authors conclude that obtained data are within acceptable ranges and routine simulation films of the bladder and rectum after administration of contrast media with dose calculations at interesting points provide important information for optimizing radiotherapy planning in the treatment of cervical carcinoma without increased time and effort or patient's discomfort.

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Vulnerability Assessment of the Climate Change on the Water Environment of Juam Reservoir (기후변화에 따른 주암호 수환경 취약성 평가)

  • Yoon, Sung Wan;Chung, Se Woong;Park, Hyung Seok
    • Proceedings of the Korea Water Resources Association Conference
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    • 2015.05a
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    • pp.519-519
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    • 2015
  • 2007년 발간된 IPCC의 4차 평가보고서에서 자연재해, 환경, 해양, 농업, 생태계, 보건 등 다양한 부분에 미치는 기후변화의 영향에 대한 과학적 근거들이 제시되면서 기후변화는 현세기 범지구적인 화두로 대두되고 있다. 또한, 기후변화에 의한 지구 온난화는 대규모의 수문순환 과정에서의 변화들과 연관되어 담수자원은 기후변화에 대단히 취약하며 미래로 갈수록 악영향을 받을 것으로 6차 기술보고서에서 제시하고 있다. 특히 우리나라는 지구온난화가 전 지구적인 평균보다 급속하게 진행될 가능성이 높기 때문에 기후변화에 대한 담수자원 취약성이 더욱 클 것으로 예상된다. 따라서 지표수에 용수의존도가 높은 우리나라의 댐 저수지를 대상으로 기후변화에 따른 수환경 변화의 정확한 분석과 취약성 평가는 필수적이다. 본 연구에서는 SRES A1B 시나리오를 적용하여 기후변화가 주암호 저수지의 수환경 변화에 미치는 영향을 분석하였다. 지역스케일의 미래 기후시나리오 생산을 위해 인공신경망(Artificial Neural Network.,ANN)기법을 적용하여 예측인자(강우, 상대습도, 최고온도, 최저온도)에 대해 강우-유출모형에 적용이 가능한 지역스케일로 통계적 상세화를 수행하였으며, 이를 유역모델에 적용하여 저수지 유입부의 유출량 및 부하량을 예측하였다. 유역 모델의 결과를 토대로 저수지 운영모델에 저수지 유입부의 유출량을 적용하여 미래 기간의 방류량을 산정하였으며, 최종적으로 저수지 모델에 유입량, 유입부하량 및 방류량을 적용하여 저수지 내 오염 및 영양물질 순환 및 분포 예측을 통해서 기후변화가 저수지 수환경에 미치는 영향을 평가하였다. 기후변화 시나리오에 따른 상세기 후전망을 위해서 기후인자의 미래분석 기간은 (I)단계 구간(2011~2040년), (II)단계 구간(2041~2070년), (III) 단계 구간(2071~2100년)의 3개 구간으로 설정하여 수행하였으며, Baseline인 1991~2010년까지의 실측값과 모의 값을 비교하여 검증하였다. 강우량의 경우 Baseline 대비 미래로 갈수록 증가하는 것으로 전망되었으며, 2011년 대비 2100년에서 연강수량 6.4% 증가한 반면, 일최대강수량이 7.0% 증가하는 것으로 나타나 미래로 갈수록 집중호우의 발생가능성이 커질 것으로 예측되었다. 유역의 수문 수질변화 전망도 강수량 증가의 영향으로 주암댐으로 유입하는 총 유량이 Baseline 대비 증가 하였으며, 유사량 및 오염부하량도 증가하는 것으로 나타났다. 저수지 수환경 변화 예측결과 유입량이 증가함에 따라서 연평균 체류시간이 감소하였으며, 기온 및 유입수온 상승의 영향으로 (I)단계 구간대비 미래로 갈수록 상층 및 심층의 수온이 상승하는 것으로 나타났다. 연중 수온성층기간 역시 증가하는 것으로 나타났으며, 남조류는 (I)단계 구간 대비 (III)단계 구간으로 갈수록 출현시기가 빨라지며 농도 역시 증가하였다. 또한 풍수년, 평수년에 비해 갈수년에 남조류의 연평균농도 상승폭과 최고농도가 크게 나타나 미래로 갈수록 댐 유입량이 적은 해에 남조류로 인한 피해 발생 가능성이 높아질 것으로 예상된다.

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Development to Hatching Blastocysts and Cell Allocation to the Inner Cell Mass and Trophectoderm of Pig In Vitro Embryos as Affected by Amino Acids and Serum (아미노산과 혈청이 돼지 수정란의 내부세포괴와 영양배엽세포로의 발달과 부화에 미치는 영향)

  • Uhm, Sang-Jun;Kim, Eun-Young;Kim, Myo-Kyung;Yi, Bong-Kyung;Lee, Hyeon-Sook;Kim, Te-Oan;Yoon, San-Hyun;Park, Se-Pill;Chung, Kil-Saeng;Lim, Jin-Ho
    • Clinical and Experimental Reproductive Medicine
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    • v.24 no.2
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    • pp.241-251
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    • 1997
  • 체외성숙과 수정된 돼지 난자의 체외발달능이 체외배발생 배양액인 NCSU 배양액에 0.4% BSA, 10% 혈청 혹은 아미노산 (2% BME 아미노산 용액과 1% MEM 아미노산 용액)을 첨가함으로서 조사되었다. 본 실험에 공시된 난자는 체외수정 추 30시간 (2-세포기)혹은 48 시간 ($2{\sim}4$-세포기)에 회수하였다. 실험I에서 0.4% BSA가 첨가된 NCSU 배양액에서 2-세포기 난자들의 배양경과시간에 따른 발달능을 조사한 결과, 배양 후 72 시간 (체외수정 후 102 시간)에 상실배기와 배반포기 배가 나타났으며, 배양 후 120 시간째 (체외수정 후 150 시간)에도 팽창된 배반포기 배까지만 발달하였다. 실험II는 체외수정 후 48 시간의 분할된 ($2{\sim}8$-세포기) 난자들의 핵과 외관적 분할구와의 수적 차이를 조사한 결과, $2{\sim}4$-세포기보다는 5-세포기 이상에서 핵과 분할구의 조화에 차이가 많았다. 실험III에서는 $2{\sim}4$-세포기 난자들을 배양후 5일째의 배반포들의 투명대의 두께, 난자 크기 그리고 inner cell mass (ICM)과 trophectoderm (TE)의 세포 배열을 조사한 결과, 난자의 크기가 커짐에 따라서 투명대가 얇아지고 전체 세포수가 증가하였지만, ICM의 비율은 차이가 없었다. 실험IV에서는 BSA, 혈청 혹은 아미노산이 첨가 혹은 무첨가된 배양액내에서 $2{\sim}4$-세포기 난자들의 배반포 후 부화능력을 조사한 결과, 모든 군에 있는 난자들은 팽창된 배반포기 배까지 발달할 수 있었던 반면, 난자의 부화는 아미노산 혹은 혈청이 포함된 배양액에서만 일어났다. 더우기 상실배기와 배반포기 시기에 혈청의 첨가는 부화 배반포기 배의 발달을 현저히 증가시켰다. 또한 아미노산과 혈청의 영향을 받은 팽창 배반포기 배는 얇은 투명대, 팽창된 난자의 크기 그리고 ICM과 전체 세포수의 증가를 보였다. 이상의 결과로 미루어 볼때, 배양액내에 대한 아미노산과 혈청의 첨가는 돼지 배반포기 배의 부화를 유도할 수 있다고 보며, 더우기 이들 요소들은 투명대의 두께, 난자의 크기 그리고 ICM과 전체 세포수에 영향을 미친다.

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Bioequivalence Test of Gabapentin 400 mg Capsules (가바펜틴 400밀리그람 캡슐의 생물학적동등성시험)

  • Kim, Se-Mi;Kang, Hyun-Ah;Cho, Hea-Young;Shin, Sae-Byeok;Yoo, Hee-Doo;Yoon, Hwa;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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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.