• Title/Summary/Keyword: Healthy volunteers

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

  • Lee, Jin-Sung;Tak, Sung-Kwon;Seo, Ji-Hyung;Kang, Jong-Min;Ryu, Ju-Hee;Yim, Sung-Vin;Hong, Seung-Jae;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.39 no.6
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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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    • v.59 no.3
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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.

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

  • Kim, Won-Joon;Lee, Kwang-Youn;Ha, Jeoung-Hee;Park, Tong-Choon
    • The Korean Journal of Pharmacology
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    • v.24 no.2
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    • pp.189-195
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    • 1988
  • This study aimed to investigate the autonomic innervations of human vas deferens and the effect of diazepam, a benzodiazepine sedative antianxiety drug, on the smooth muscle contractility of vas deferens. The specimens were obtained from healthy volunteers undergoing elective vasectomy with local anesthesia. The muscle preparation did not show any spontaneous contraction, but showed a good contraction induced by norepinephrine exerting the strongest response at $33^{\circ}C$. Phentolamine inhibited the norepinephrine-induced contraction concentration-dependently. Isoproterenol, a beta-adrenergic agonist evoked a considerable extent of contraction, and this contractile activity was antagonized by propranolol, a beta-adrenergic blocking agent. Acetylcholine induced a dashing contraction of the human vas deferens, and atropine, a muscarinic receptor blocking agent abolished the acetylcholine-induced contraction. Diazepam inhibited the norepinephrine-induced contraction in a concentration dependent manner. These results suggest that the smooth muscle of human vas deferens has cholinergic muscarinic and beta adrenergic receptors as well as the predominant alpha adrepergic receptor. Diazepam inhibits the motility, especially norepinephrine-induced contraction of human vas deferens.

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

  • Joo, Kyung-Mi;Han, Ji-Yeon;Son, Eui-Dong;Nam, Gae-Won;Jeong, Hye-Jin;Lim, Kyung-Min;Cho, Jun-Cheol
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.38 no.1
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    • pp.75-82
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    • 2012
  • Natural moisturizing factors (NMFs) are hydrophilic and water-soluble components in stratum corneum of the skin. NMFs absorb water from outer environment and enhance the water-holding capacity of stratum corneum and thereby, prevent the dryness and increase flexibility and plasticity of skin. NMFs are mainly composed of amino acids and their metabolites that are produced from the degradation of filaggrin. Here we established a simultaneous quantification method for 22 amino acids in tape-stripped stratum corneum samples using UPLC-PDA. With this method, we analyzed amino acid contents from tape-stripped stratum corneum samples of forearm and forehead regions from 15 healthy volunteers. Amino acid contents of inner (or upper) region were higher than outer (or lower) region of stratum corneum. Amino acid contents of stratum corneum of forearm were higher by 1.5 fold than forehead region. Of note, total amino acid contents were significantly and inversely correlated with trans-epidermal water loss (TEWL), an index for skin barrier function. Especially, Ser, Glu, Gly, Ala and Thr were determined to positively affect skin mositurizing activities. In conclusion, we could demonstrate that amino acid contents of stratum corneum are closely linked with skin barrier and moisturizing function, providing an important and fundamental methodology for the study of amino acids in skin physiology.

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

  • Park, Shin-Young;Nam,, Gae-Won;Kim, Seung-Hun;Lee, Hea-Kang;Ahn, Sung-Yeon;Moon, Seong-Joon;Kim, Han-Kon
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.34 no.4
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    • pp.333-338
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    • 2008
  • The evaluation for the visage volume was performed with human and dummy face using PRIMOS $body^{(R)}$. Three researchers measured the dummy face attached different volume of clay (6.6 mL, 13.2 mL, and 19.8 mL). It is identified that the high correlation between measured values and real volume ($R^2=0.99$). The percent (%) of relative standard deviation (RSD) of the data was shown below 10%. In Gage R&R analysis, the percent of contribution, the percent of study variation and distinct categories values were 0.78%, 8.85%, and 15% respectively. Therefore this method was regarded as the good standard condition in aspect of reproducibility and repetitiveness of data. The face volume variation was measured by PRIMOS $body^{(R)}$ on the face in participated 10 healthy Korean women volunteers. Subjects used the product once a day for two weeks as night sleeping pack. After application of the test products, the 3D image data of face were taken 1 and 2 weeks later. We found the face volume was significantly decreased after using products. In conclusion, this novel non-invasive technique was useful in measuring and visualizing alterations in face volume as a consequence of certain treatments. This system will provide a rapid and precise analysis of 3D topographical information for face.

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

  • Kim, Hak-Sung;Ma, Sang-Chull
    • Journal of radiological science and technology
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    • v.32 no.2
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    • pp.169-175
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    • 2009
  • This study examined 40 healthy volunteers had been tested for their gallbladder (GB) volume and wall thickness by a real time ultrasonography before and after a meal. The results are as follows : 1. The mean values of GB volume were 47.40. (SD 9.05) for male, 35.72. (SD 8.30) for female. 2. The mean value of wall thickness of GB was 2.3 mm (SD 0.3, male, SD 0.5, female). 3. The mean ejection-fraction rates of GB result in 67.20% for male, 63.95% for female. 4. The values of GB volume had significant negative correlations (v = -.487, p < .000, male, v = -.509, p < .000, female) within 4 hours after a meal and significant positive correlations (v = .434, p < .000, male, v = .440, p < .000, female) afterward. 5. The wall thicknesses of GB were significant positive correlations (t = .310, p < .002, male, t = .116, p < .246, female) within 3 hours after a meal and significant negative correlations (t = -.288, p < .010, male, t = -.126, p < 7.10, female) afterward. 6. The relationship between volume and wall thickness of GB showed significant negative correlation.

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

  • 이영숙
    • Journal of Korean Academy of Nursing
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    • v.26 no.1
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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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    • v.30 no.4
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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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    • v.5 no.4
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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.

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

  • Cho, Hea-Young;Choi, Ji-Hoon;Yoo, Hee-Doo;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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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.