• 제목/요약/키워드: Healthy volunteers

검색결과 866건 처리시간 0.026초

모빅캡슐(멜록시캄 7.5mg)에 대한 멜록시펜캡슐의 생물학적 동등성 (Bioequivalence of MeloxifenTM Capsule to MobicTM Capsule(Meloxicam 7.5 mg))

  • 이진성;탁성권;서지형;강종민;류주희;임성빈;홍승재;이경태
    • Journal of Pharmaceutical Investigation
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    • 제39권6호
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    • pp.457-463
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    • 2009
  • The purpose of the present study was to evaluate the bioequivalence of meloxicam capsule, $Mobic^{TM}$ capsule( Boehringer Ingelheim Ltd., Korea) as a reference drug and $Meloxifen^{TM}$ capsule (Kukje Pharma Ind. Co., Ltd., Korea) as a test drug, according to the guidelines of Korea Food and Drug Administration(KFDA). Thirty two healthy male Korean volunteers received capsule containing meloxicam 7.5 mg in a $2{\times}2$ crossover study. There was a one-week above washout period between the doses. Plasma concentrations of meloxicam were monitored for over a period of 72 hr after administration by using a high performance liquid chromatography-tandem mass spectrometer(LC-MS/MS). $AUC_t$(the area under the plasma concentration-time curve from time zero to 72 hr), $C_{max}$(maximum plasma drug concentration) and $T_{max}$(time to reach $C_{max}$) were complied from the plasma concentration-time data. Analysis of variance(ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Meloxifen^{TM}/Mobic^{TM}$ were log 0.8605-log 0.9847 and log 0.9765-log 1.1503, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25, recommended by KFDA. In all of these results, we concluded that $Meloxifen^{TM}$ capsule was bioequivalent to $Mobic^{TM}$ capsule, based on the rate and extent of absorption.

Sagittal Pelvic Radius in Low-Grade Isthmic Lumbar Spondylolisthesis of Chinese Population

  • Zhao, Yang;Shen, Cai-Liang;Zhang, Ren-Jie;Cheng, Da-Wei;Dong, Fu-Long;Wang, Jun
    • Journal of Korean Neurosurgical Society
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    • 제59권3호
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    • pp.292-295
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    • 2016
  • Objective : To investigate the variation of pelvic radius and related parameters in low-grade isthmic lumbar spondylolisthesis. Methods : Seventy-four patients with isthmic lumbar spondylolisthesis and 47 controls were included in this study. There were 17 males and 57 females between 30 and 66 years of age, including 30 with grade I slippages and 44 grade II slippages; diseased levels included 34 cases on L4 and 40 cases on L5. Thoracic kyphosis (TK), the pelvic radius (PR), the pelvic angle (PA), pelvic morphology (PR-S1), and total lumbopelvic lordosis (PR-T12) were assessed from radiographs. Results : Statistically significant differences were found for the PA, PR-T12, and PR-S1 ($24.5{\pm}6.6^{\circ}$, $83.7{\pm}9.8^{\circ}$, and $25.4{\pm}11.2^{\circ}$, respectively) of the patients with spondylolisthesis and the healthy volunteers ($13.7{\pm}7.8^{\circ}$, $92.9{\pm}9.2^{\circ}$, and $40.7{\pm}8.9^{\circ}$, respectively). The TK/PR-T12 ratios were between 0.15 and 0.75. However, there were no differences in all the parameters between the L4 and L5 spondylolysis subgroups (p>0.05). The TK and PR-S1 of grade II were less than grade I, but the PA was greater. The PR-T12 of female patients were less than male patients, but the PA was greater (p<0.05). Conclusion : Pelvic morphology differed in patients with low-grade isthmic lumbar spondylolisthesis compared to controls. Gender and the grade of slippage impacted the sagittal configuration of the pelvis, but the segment of the vertebral slip did not. Overall, the spine of those with spondylolisthesis remains able to maintain sagittal balance despite abnormal pelvic morphology.

인체 정관의 약리학적 검색 -아드레날린성 및 콜린성 수용체의 공존과 Diazepam의 작용- (Pharmacological Studies on Human Vas Deferens -Coexistence of Adrenergic and Cholinergic Receptors, and Effect of Diazepam-)

  • 김원준;이광윤;하정희;박동춘
    • 대한약리학회지
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    • 제24권2호
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    • pp.189-195
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    • 1988
  • 인체 정관 평활근에서 각종 자율신경전달체 수용체의 유무를 조사하고 benzodiazepine계의 진정-항불안제인 diazepam이 평활근 운동성에 미치는 작용을 관찰하기 위하여, 32내지 45세의 건강한 지원자로부터 정관절편을 얻었다. 정관 절제술은 국소마취하에 시행되었고, 정관절편의 수축력 측정은 등장성장력측정기에 의하였다. 적출장기실험조 내에서 정관절편의 자율수축은 관찰되지 않았으나, norepinephrine에 대한 반응성은 $33^{\circ}C$에서 가장 예민하였던 바, 이 norepinephrine에 의한 농도의존적 수축력증가작용은 알파-아드레날린성 차단제인 phentolamine에 의해 억제되었다. 또 인체 정관절편은 본 실험의 조건하에서 isoproterenol 의하여 수축하였고, 이 수축작용은 베타-아드레날린성 차단제인 propranolol 의하여 완전히 제거되었다. 동시에 인체 정관절편은 acetylcholine에의해서도 비교적 강하게 수축하였고, 이 수축작용은 콜린성 무스카린성 차단제인 atropine에 의하여 완전히 억제되었다. Diazepam은 norepinephrine에 의한 수축을농도 의존적으로 억 제 하였다. 이상의 결과를 종합하면, 인체 정관 평활근은 체온보다 낮은 $33^{\circ}C$에서 그 활동성이 가장 강하고, 자율신경에 대하여서는 아드레날린성 및 콜린성 수용체가 공존하고 있으며, diazepam은 그 수축력을 약화시킨다고 사료된다.

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아미노산 동시분석을 통한 피부보습능과 각질 중 아미노산 함량과의 상관관계 연구 (Study on the Relationship between Skin Dryness and Amino Acids in Stratum Corneum)

  • 주경미;한지연;손의동;남개원;정혜진;임경민;조준철
    • 대한화장품학회지
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    • 제38권1호
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    • pp.75-82
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    • 2012
  • 천연보습인자(NMF, natural moisturizing factor)는 정상 피부 내의 각질층에 존재하는 수용성, 친수성 성분을 총칭하는 말로 외부로부터 수분을 흡수하고 각질층의 수분보유능을 증가시키며 피부가 건조해지는 것을 방지하여 피부의 유연성과 가수성을 유지하는 기능을 한다. NMF는 주로 아미노산과 아미노산의 대사산물로 구성되며 이들은 필라그린(filaggrin)이 분해되면서 생성된다. 본 연구에서는 피부 각질층의 22종의 개별 아미노산의 함량분석을 통하여 피부보습능과 개개의 아미노산과의 상관관계를 연구하였다. 15명의 건강한 지원자들의 전박과 이마로부터 tape stripping한 각질 시료 중 22종의 아미노산 함량을 UPLC-PDA를 이용하여 동시 분석하였다. 그 결과 각질 표면보다는 안쪽에서의 아미노산들의 함량이 높음을 확인하였다. 또한 신체 부위별 비교에서 전박이 이마에 비해 아미노산 함량이 1.5배 정도 높음을 확인하였다. 전박부위의 아미노산 총 함량과 보습능(TEWL)과의 상관 관계분석을 통해서는 보습능이 클수록 총아미노산 함량이 높은 것으로 확인되었으며 특히 Ser, Glu, Gly, Ala 및 Thr은 각질 내 존재하는 주요 아미노산 성분으로 보습에 긍정적인 영향을 주는 성분으로 확인되었다. 이상의 결과로써 NMF의 주성분인 아미노산의 함량은 각질 생리기능과 밀접한 관련을 가지고 있음을 확인할 수 있었으며 본 연구를 통해 얻은 각질층의 아미노산의 통합적인 분석법은 보습, 노화, 미백, 피부 염증질환 등 다양한 피부 상태와 아미노산류들의 변화와의 관계를 깊이 이해하고 피부 기능과 관련된 새로운 분자적 타겟을 발굴하고 증명하는데 기초적인 방법으로써 사용될 수 있을 것으로 사료된다.

3D 측정 기기를 이용한 얼굴의 부피 정량법 연구 (A Quantitative Method for Human Face Volume Using 3D Optical Measurement)

  • 박신영;남개원;김승훈;이해광;안성연;문성준;김한곤
    • 대한화장품학회지
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    • 제34권4호
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    • pp.333-338
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    • 2008
  • PRIMOS $body^{(R)}$ 기기를 이용한 얼굴부피 평가법 개발에 관한 연구를 진행하였다. 평가법의 신뢰성을 확인하고자 세 명의 시험자가 마네킹과 사람을 대상으로 얼굴 부피를 측정하였다. 마네킹의 얼굴에 여러 가지 부피의 찰흙을 붙이고, 기기로 얼굴을 측정하였는데, 실제 찰흙의 부피와 측정값 사이에 높은 상관성($R^2=0.99$)이 있는 것으로 나타났다.% RSD와 Gage R&R 분석으로 기기의 정확성, 반복성, 재현성을 확인한 결과 신뢰성이 있는 결과를 얻었다. 이와 같은 평가법을 얼굴 붓기 감소에 영향을 주는 화장품의 효능을 평가하는데 적용하였다. 10명의 건강한 여성을 대상으로 화장품 사용 전후 얼굴의 부피를 측정한 결과, 얼굴의 부피가 감소하는 것으로 나타났다. 이와 같은 결과를 통해 PRIMOS $body^{(R)}$를 이용한 얼굴 부피 평가법은 인체평가에 유용하게 사용될 수 있을 것으로 보인다.

20대 정상 성인군에서 식후 쓸개용적과 벽두께의 시간적 변화에 대한 평가 (Evaluation for Sequential Changes on Gallbladder Volume and Wall Thickness in Normal Young Adults)

  • 김학성;마상철
    • 대한방사선기술학회지:방사선기술과학
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    • 제32권2호
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    • pp.169-175
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    • 2009
  • 본 연구는 초음파진단장치의 3.5 MHz 프로브로 20대 정상 성인의 식전 후 쓸개용적과 쓸개벽두께를 시간별로 추적주사하고 이것들의 추이변화를 분석 평가하여 다음과 같은 결론을 얻었다. 1. 식전 평균 쓸개용적은 남자 47.40 $m\ell$(SD 9.05), 여자 35.72 $m\ell$(SD 8.30)이었다. 2. 식전 평균 쓸개벽두께는 남 여 모두 2.3 mm(SD 0.3, SD 0.5)이었다. 3. 평균 쓸개박출계수(%)는 남자 67.20%, 여자 63.95%이었다. 4. 쓸개용적은 남 여 모두 식후 4시간까지는 음상관관계(v = -.487, p < .000, v = -.509, p < .000), 4시간 이후는 순상관관계(v = .434, p < .000, v = .440, p < .000)를 보였다. 5. 쓸개벽두께는 남 여 모두 식후 3시간까지는 순상관관계(t = .310, p < .002, t = .116, p < .246), 3시간 이후는 음상관관계(t = -.288, p < .010, t = -.126, p < 7.10)를 보였다. 6. 남 여 쓸개용량과 벽두께의 시간별 추이는 역상관관계를 나타냈다.

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질회음 근육운동이 기혼여성의 성기능에 미치는 효과 (The Effect of Circumvaginal Muscle Exercise on Sexual Function in Married Women)

  • 이영숙
    • 대한간호학회지
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    • 제26권1호
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    • pp.148-164
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    • 1996
  • The effect of circumvaginal muscle(CVM) exercises to improve sexual function in married women has not been investigated by currently acceptable research methods, nor have appropriate instruments and techniques to carry out such investigation been available. The purpose of this research was to study the effect of CVM exercise on sexual function, and of measuring CVM function after CVM exercises. The research tools used were a modified Derogates Sexual Function Inventory questionnaire and a pressure sensitive intravaginal balloon device. This research was conducted in Kwangju-city and Chonnam province, Korea from July, 1994 to July, 1995. The research used a non-equivalent control pre-post test quasi-experimental design. Forty-five healthy married female volunteers, aged 30-58, and were randomly assigned by age using the matching fixed-length blocks to two groups. The experimental group consisted of 21 women who were assigned a 25-minute per day CVM home exercise program for six weeks. The control group of 24 women did not do the CVM home exercises. The CVM home exercise was developed by Dougherty(1989a) and adopted to Korea by Lee (1993). Data were analyzed by $x^{2-}$test, Paired t-test, Spearman product-moment correlation using SAS /P $C^+. The results are summarized as follows : 1. There were no significant differences in the characteristics of the subjects between the experimental and control groups before the CVM home exercises. 2. Hypothesis 1 that married women who participated in CVM home exercises would have higher mean scores on the sexual function(SF) than in those who did not participate in home exercise was supported. 3. Hypothesis 2 that married women who participated in CVM home exercises would have higher vaginal pressure on SF than in those who did not participate in home exercises was supported (mean maximum pressure, t=-7.338, P<.0001, peak maximum pressure, t=-11.164, P<.0001). 4. Hypothesis 3 that the more often(number of days) and the more frequent (numbers of time per day) that married women do CVM home exercise, the higher their mean scores on SF and vaginal pressures was supported(r=0.233, P<.01 ; r=0.352, P<.05). A six week CVM home exercise program using a tape recording showed that SF can be improved. Results of this study showed that married women who exercise on a regular basis for six weeks improve their sexual function and increase the mean vaginal pressure and peak maximum pressure (tested by electronic monitor). In conclusion, CVM exercise is effective in increasing SF.SF.

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Radiation-induced Apoptosis, Necrosis and G2 Arrest in Fadu and Hep2 Cells

  • Lee Sam-Sun;Kang Beom-Hyun;Choi Hang-Moon;Jeon In-Seong;Heo Min-Suk;Choi Soon-Chul
    • Imaging Science in Dentistry
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    • 제30권4호
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    • pp.275-279
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    • 2000
  • Purpose: Radiation damage is produced and viable cell number is reduced. We need to know the type of cell death by the ionizing radiation and the amount and duration of cell cycle arrest. In this study, we want to identified the main cause of the cellular damage in the oral cancer cells and normal keratinocytes with clinically useful radiation dosage. Materials and Methods: Human gingival tissue specimens obtained from healthy volunteers were used for primary culture of the normal human oral keratinocytes (NHOK). Primary NHOK were prepared from separated epithelial tissue and maintained in keratinocyte growth medium containing 0.15 mM calcium and a supplementary growth factor bullet kit. Fadu and Hep-2 cell lines were obtained from KCLB. Cells were irradiated in a /sup 137/Cs γ-irradiator at the dose of 10 Gy. The dose rate was 5.38 Gy/min. The necrotic cell death was examined with Lactate Dehydrogenase (LDH) activity in the culture medium. Every 4 day after irradiation, LDH activities were read and compared control group. Cell cycle phase distribution and preG1-incidence after radiation were analyzed by flow cytometry using Propidium Iodine staining. Cell cycle analysis were carried out with a FAC Star plus flowcytometry (FACS, Becton Dickinson, USA) and DNA histograms were processed with CELLFIT software (Becton Dickinson, USA). Results: LDH activity increased in all of the experimental cells by the times. This pattern could be seen in the non-irradiated cells, and there was no difference between the non-irradiated cells and irradiated cells. We detected an induction of apoptosis after irradiation with a single dose of 10 Gy. The maximal rate of apoptosis ranged from 4.0% to 8.0% 4 days after irradiation. In all experimental cells, we detected G2/M arrest after irradiation with a single dose of 10 Gy. Yet there were differences in the number of G2/M arrested cells. The maximal rate of the G2/M ranges from 60.0% to 80.0% 24h after irradiation. There is no significant changes on the rate of the G0/G1 phase. Conclusion: Radiation sensitivity was not related with necrosis but cell cycle arrest and apoptosis. These data suggested that more arrested cell is correlated with more apoptosis.

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Ulcerative Colitis is Associated with Novel Polymorphisms in the Promoter Region of MIP-3${\alpha}$/CCL20 Gene

  • Choi, Suck-Chei;Lee, Eun-Kyung;Lee, Sung-Ga;Chae, Soo-Cheon;Lee, Myeung-Su;Seo, Geom-Seog;Kim, Sang-Wook;Yeom, Joo-Jin;Jun, Chang-Duk
    • IMMUNE NETWORK
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    • 제5권4호
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    • pp.205-214
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    • 2005
  • Background: We examined global gene expression profiles of peripheral blood mononuclear cells (PBMCs) in patients with ulcerative colitis (DC), and tested whether the identified genes with the altered expression might be associated with susceptibility to UC. Methods: PBMCs from 8 UC and 8 normal healthy (NH) volunteers were collected, and total RNAs were subjected to the human 8.0K cDNA chip for the micro array analysis. Real time-PCR (RT-PCR) was performed to verify the results of micro array. One hundred forty UC patients and 300 NH controls were recruited for single nucleotide polymorphism (SNP) analysis. Results: Twenty-five immune function-related genes with over 2-fold expression were identified. Of these genes, two chemokines, namely, CXCL1 and CCL20, were selected because of their potential importance in the evocation of host innate and adaptive immunity. Four SNPs were identified in the promoter and coding regions of CXCL1, while there was no significant difference between all patients with UC and controls in their polymorphisms, except minor association at g.57A>G (rs2071425, p=0.02). On the other hand, among three novel and one known SNPs identified in the promoter region of CCL20, g. -1,706 G>A (p=0.000000055), g. -1,458 G>A (p=0.0048), and g. -962C>A (p=0.0006) were found to be significantly associated with the susceptibility of Uc. Conclusion: Altered gene expression in mononuclear cells may contribute to IBD pathogenesis. Although the findings need to be confirmed in other populations with larger numbers of patients, the current results demonstrated that polymorphisms in the promoter region of CCL20 are positively associated with the development of Uc.

밤벡$^{(R)}$ 정 10밀리그람(염산밤부테롤 10밀리그람)에 대한 밤부콜 정 10밀리그람의 생물학적동등성 (Bioequivalence of Bambucol Tablet 10 mg to $Bambec^{(R)}$ Tablet 10 mg (Bambuterol Hydrochloride 10 mg))

  • 조혜영;최지훈;류희두;이용복
    • 한국임상약학회지
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    • 제20권3호
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    • pp.235-241
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    • 2010
  • Bambuterol hydrochloride, dimethylcarbamic acid 5-[2-(1,1-dimethylethyl)amino-1-hydroxyethyl]-1,3-phenylene ester hydrochloride, is the prodrug of active ${\beta}_2$-adrenergic metabolite terbutaline. The purpose of the present study was to evaluate the bioequivalence of two bambuterol hydrochloride tablets, $Bambec^{(R)}$ tablet 10 mg (Yuhan Co., Ltd.) and Bambucol tablet 10 mg (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). In vitro release of bambuterol from two bambuterol hydrochloride formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male Korean volunteers, $23.86{\pm}1.65$ years in age and $68.98{\pm}9.58$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 10 mg as bambuterol hydrochloride were orally administered, blood samples were taken at predetermined time intervals, and the concentrations of bambuterol in serum were determined using column switching 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 with K-BE Test 2002 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, $Bambec^{(R)}$, were -8.10%, -3.82% and 12.65% 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 (i.e., log 0.8093~log 1.0302 and log 0.8564~log 1.1280 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Bambucol tablet 10 mg was bioequivalent to $Bambec^{(R)}$ tablet 10 mg.