• Title/Summary/Keyword: test sequence

Search Result 1,291, Processing Time 0.027 seconds

Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers

  • Park, Jun-Sung;Myung, Ja-Hye;Wang, Hun-Sik;Koo, Ja-Seong;Cho, Won-Kyung;Cha, Kwang-Ho;Park, Hee-Jun;Kim, Min-So;Kim, Jeong-Soo;Hwang, Sung-Joo
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.3
    • /
    • pp.191-196
    • /
    • 2011
  • In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{\pm}223.4$ $ng{\cdot}h{\cdot}mL^{-1}$, $177.4{\pm}34.2$ $ng{\cdot}mL^{-1}$, and $0.8{\pm}0.4$ and $3.5{\pm}2.1$, respectively, for the test formulations, and $640.7{\pm}186.6$ $ng{\cdot}h{\cdot}mL^{-1}$, $193.0{\pm}64.5$ $ng{\cdot}mL^{-1}$, and $0.9{\pm}0.4$ and $2.7{\pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.

Bioequivalence of Cadilan Tablet 12.5 mg to Dilatrend® Tablet 12.5 mg (Carvedilol 12.5 mg) (딜라트렌 정 12.5밀리그람(카르베딜롤 12.5밀리그람)에 대한 카딜란 정 12.5밀리그람의 생물학적동등성)

  • Kim, Se-Mi;Shin, Sae-Byeok;Kim, Ju-Hwan;Kwon, In-Ho;Kim, Yong-Hee;Lee, Sang-No;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.38 no.6
    • /
    • pp.413-419
    • /
    • 2008
  • Carvedilol, is a nonselective $\beta$-blocking agent and it also has vasodilating properties that are attributed mainly to its blocking activity at ${\alpha}_1$-receptors. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{(R)}$ tablet 12.5 mg (Chong Kun Dang Pharmaceutical Co., Ltd.) and Cadilan tablet 12.5 mg (KyungDong Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of carvedilol from the two carvedilol formulations in vitro was tested using KP VIII Apparatus II method with pH 4.5 dissolution medium. Thirty two healthy male subjects, $25.00{\pm}3.09$ years in age and $70.71{\pm}11.35\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 12.5 mg as carvedilol was orally administered, blood samples were taken at predetermined time intervals and the concentrations of carvedilol 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, $Dilatrend^{(R)}$ tablet 12.5 mg, were 4.66%, 8.33% and -7.45% 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., $\log\;0.9823{\sim}\log\;1.1042$ and $\log\;1.0132{\sim}\log\;1.1875$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Cadilan tablet 12.5 mg was bioequivalent to $Dilatrend^{(R)}$ tablet 12.5 mg.

Characterization of Antibacterial Substance - Producing Bacillus subtilis Isolated from Traditional Doenjang (전통 된장으로부터 분리한 향균물질 생산 Bacillus subtilis의 특성)

  • Ryu, Hyun-Soon;Shon, Mi-Yae;Cho, Soo-Jeong;Park, Seok-Kyu;Lee, Sang-Won
    • Applied Biological Chemistry
    • /
    • v.50 no.2
    • /
    • pp.87-94
    • /
    • 2007
  • A bacterium which has high enzymatic activities such as amylase, cellulase and protease was isolated from Korean traditional soybean food, doenjang. The isolated bacterium was identified to Bacillus subtilis HS25 by the test of morphological and biochemical properties according to Bergey's Manual of Systematic Bacteriology and API 50 CHL kit, and by the 16S rDNA sequence. The isolated B. subtilis HS25 had a potent antibacterial activity against food born causative or pathogenic bacteria. B. subtilis HS25 is endospore forming cell and contained flagella and abundant viscous material at the out layer of cell wall. It was rod type bacterium $(0.5{\sim}0.8{\times}3{\sim}5{\mu}m)$ having biochemical characteristics such as gram staining(+), catalase(+), oxidase(-) and hydrolysis of esculin(+). The optimal medium compositions for production of antibacterial substance in the B. subtilis HS25 were 1% of soluble starch, 0.5% of yeast extract, 0.5% of peptone and 0.05% of MgCl$_2{\cdot}6H_{2}O$. The optimum temperature and pH of the growth of the B. subtilis HS25 was 35$^{\circ}C$ and pH 7.5, respectively. The antibacterial activity was more high in neutral to a little alkaline pH (6.5-10.5) than in acidic pH. The optimal shaking speed to grow and to produce antibacterial substance of the B. subtilis HS25 was 160${\sim}$200 rpm. The optimal culture time for antibacterial activities of the bacterium were shown to be in the range of 12-36 hr.

Phylogenetic study of the section Adonanthe of genus Adonis L. (Ranunculaceae) based on ITS sequences (ITS 염기서열에 의한 복수초속 복수초절(미나리아재비과)의 계통분류학적 연구)

  • Son, Dong Chan;Park, Beom Kyun;Ko, Sung Chul
    • Korean Journal of Plant Taxonomy
    • /
    • v.46 no.1
    • /
    • pp.1-12
    • /
    • 2016
  • DNA sequences of nrITS regions obtained from 49 accessions representing 12 species and one variety within the section Adonanthe of the genus Adonis were analyzed to test the previous intra-sectional classification system and to determine their phylogenetic relationships. The results showed that the seven accessions of A. amurensis Regel et Radde included in the present study did not form a monophyletic group, as some of the accessions showed a close relationship with the Japanese endemic species A. ramosa Franch., which implies that the current species delimitation and identification of A. amurensis is problematic. Adonis pseudoamurensis W. T. Wang, which is frequently misidentified as A. ramosa in Korea, formed a segregated group, which suggests that they should not be considered as conspecific taxa. Accessions from A. shikokuensis Nishikawa et Koji Ito, A. multiflora Nishikawa et Koji Ito, and A. pseudoamurensis formed a clade, but monophyly of each species was not evident. The nrITS data did not support the classification system proposed by Wang, who classified sect. Adonanthe into four series, as most of these were found to be either polyphyletic or paraphyletic.

The Development of a Multi-Purpose Irradiator and the Characteristic of Dose Distribution (다목적 방사선 조사장치 개발 및 선량분포특성)

  • Lee, Dong-Hoon;Ji, Young-Hoon;Lee, Dong-Han;Kim, Yoon-Jong;Hong, Seung-Hong
    • Journal of the Institute of Electronics Engineers of Korea SC
    • /
    • v.39 no.6
    • /
    • pp.42-48
    • /
    • 2002
  • The design, construction and performance test of a convenient multi-purpose irradiator is described. A multi-purpose irradiator using Cesium-137 has been developed for studies of low dose radiation effects in biology and for calibration of Thermo Luminescent dosimeter(TLD). During the operation, three rods of radioactive material which are 10cm in length revolve 180 degrees and irradiate biological samples, or TLD, and return to their shielded position, after the programmed time. A programmable Logic Controller(PLC) controls the sequence of operation, interlock, motor rotation and safety system. The rotation speed of biological samples can vary up to 20 RPM. A real time monitoring system was also incorporated to check and control the operation status of the irradiator. The capacity of the irradiation chamber was 4.5 liters. The isodose distribution at arbitrary vertical planes was measured by using film dosimetry. The dose-rate was 0.13 cGy/min in air and 0.11 cGy/min in water equivalent material in the case of Cesium-137. Range of activity was 2 Ci. The homogeneity of dose distribution in the chamber was ${\pm}$7%. The actual radiation level on the surface was within permissible levels. The irradiator had a maximum 0.35 mR/min radiation leakage on its surface.

A Study of the Casual Wear Purchase Behavior of the Adult Males (성인남성의 캐주얼의복 구매행동에 관한 연구)

  • 신수윤;김영덕
    • The Research Journal of the Costume Culture
    • /
    • v.7 no.4
    • /
    • pp.99-110
    • /
    • 1999
  • In order to help the marketers of the men\`s casual wear brands establish the marketing strategies to their target consumers, it is the purpose of this study to investigate on the variables affecting the casual wear purchase behavior of men in twenties, thirties and forties, and to clarify the differences of casual wear purchase behavior according to their age, The subjects were 429 men in their twenties, thirties and forties living in Seoul and data were analyzed by frequency, percentage, mean and standard deviation, x², ANOVA and Duncan\`s test. The results were as follows : (1) Significant differences were found among men in twenties, thirties and forties according to the self-image. Men in forties favored the conservative and not-noticeable image of casual wear, however, men in twenties and thirties favored those of the active, sexy, and distinctive image. (2) Significant differences were found among men in twenties, thirties and forties according to the importance of the store attributes such as convenience of transportation and parking place, clothing in vogue, and various merchandise. Men in thirties and forties put more importance on convenience of transportation and parking place. Men in forties put more importance on various merchandise than men in twenties and thirties. (3) Significant differences were found among men in twenties, thirties and forties according to general purchase behavior of casual wear. * Differences of the use of information according to age Majority of the men consulted the T.V., radio and people in their boundaries * Differences of the clothing purchase frequency according to age Men in twenties buy more clothing than other age groups. Men in twenties buy the clothing every one month and every three months and men in thirties and forties buy the clothing every three months and every six months. * Differences of the shopping day according to age Majority of the men buy the clothing on Saturday and Sunday. However men in twenties buy the clothing more on weekdays than other age groups. * Differences of the shopping place according There were not significant differences among three different age groups and majority of the men found out to utilize the department store. * Differences of the influence of the partners according to age Men in twenties found out to rely on their own decisions but men in thirties and forties found out to depend on their wives(loves). * Differences of the selection standards of casual wear according to age There were not significant differences according to age and adult males found out to select the casual wear by design, quality price in sequence.

  • PDF

A Study on the Optimum Cross-section and Tendon Profiles of 60 m span Half-Decked PSC Girder Bridge (Half-Deck을 포함한 60 m 경간 PSC 거더의 단면 및 텐던 프로파일 최적화 연구)

  • Kim, Tae Min;Kim, Do-Hak;Kim, Moon Kyum;Lim, Yun Mook
    • KSCE Journal of Civil and Environmental Engineering Research
    • /
    • v.31 no.6A
    • /
    • pp.417-424
    • /
    • 2011
  • This study focused on development of 60 m span PSC girder considering not only structural performance, but also economical efficiency and constructability including from the improvement of cross-section to the tendon profiles in sequence. Bulb-T type cross section was derived from optimization and actual possibilities to design a bridge were assessed through cross section evaluation. Tendons were also arranged efficiently so that the girder could resist the service load effectively. After developed girder was applied to a sample bridge, result of finite element analysis proved all load steps were satisfied with the allowable stress. Furthermore, it seemed that sufficient redundancy will be available to design a bridge safely. Based on these, a full-scale 60 m span girder was fabricated and 4 point bending test was performed. An initial crack occurred over twice of the service load in this experiment, which establishes adequate structural performance. 60 m span Half-Decked PSC girder developed in this study has a lower height for the given span which resulted from cross section improvement and efficient tendon layout. This girder also has not only the structural advantage, but also advantages in economical efficiency and constructability.

Software development for the visualization of brain fiber tract by using 24-bit color coding in diffusion tensor image

  • Oh, Jung-Su;Song, In-Chan;Ik hwan Cho;Kim, Jong-Hyo;Chang, Kee-Hyun;Park, Kwang-Suk
    • Proceedings of the KSMRM Conference
    • /
    • 2002.11a
    • /
    • pp.133-133
    • /
    • 2002
  • Purpose: The purpose of paper is to implement software to visualize brain fiber tract using a 24-bit color coding scheme and to test its feasibility. Materials and Methods: MR imaging was performed on GE 1.5 T Signa scanner. For diffusion tensor image, we used a single shot spin-echo EPI sequence with 7 non-colinear pulsed-field gradient directions: (x, y, z):(1,1,0),(-1,1,0),(1,0,1),(-1,0,1),(0,1,1),(0,1,-1) and without diffusion gradient. B-factor was 500 sec/$\textrm{mm}^2$. Acquisition parameters are as follows: TUTE=10000ms/99ms, FOV=240mm, matrix=128${\times}$128, slice thickness/gap=6mm/0mm, total slice number=30. Subjects consisted of 10 normal young volunteers (age:21∼26 yrs, 5 men, 5 women). All DTI images were smoothed with Gaussian kernel with the FWHM of 2 pixels. Color coding schemes for visualization of directional information was as follows. HSV(Hue, Saturation, Value) color system is appropriate for assigning RGB(Red, Green, and Blue) value for every different directions because of its volumetric directional expression. Each of HSV are assigned due to (r,$\theta$,${\Phi}$) in spherical coordinate. HSV calculated by this way can be transformed into RGB color system by general HSV to RGB conversion formula. Symmetry schemes: It is natural to code the antipodal direction to be same color(antipodal symmetry). So even with no symmetry scheme, the antipodal symmetry must be included. With no symmetry scheme, we can assign every different colors for every different orientation.(H =${\Phi}$, S=2$\theta$/$\pi$, V=λw, where λw is anisotropy). But that may assign very discontinuous color even between adjacent yokels. On the other hand, Full symmetry or absolute value scheme includes symmetry for 180$^{\circ}$ rotation about xy-plane of color coordinate (rotational symmetry) and for both hemisphere (mirror symmetry). In absolute value scheme, each of RGB value can be expressed as follows. R=λw|Vx|, G=λw|Vy|, B=λw|Vz|, where (Vx, Vy, Vz) is eigenvector corresponding to the largest eigenvalue of diffusion tensor. With applying full symmetry or absolute value scheme, we can get more continuous color coding at the expense of coding same color for symmetric direction. For better visualization of fiber tract directions, Gamma and brightness correction had done. All of these implementations were done on the IDL 5.4 platform.

  • PDF

Repression of HspA2 mRNA Expression in Human Testes with Abnormal Spermatogenesis (비정상적 정자형성 환자의 정소에서 Heat Shock Protein A2 (hspA2) mRNA 발현의 감소)

  • Son, W.Y.;Hwang, S.H.;Han, C.T.;Lee, J.H.;Kim, S.J.;Kim, Y.C.
    • Clinical and Experimental Reproductive Medicine
    • /
    • v.26 no.1
    • /
    • pp.103-109
    • /
    • 1999
  • Objective: Heat shock protein 70-2 (Hsp70-2) gene knockout mice are found to have premeiotic arrest at the primary spermatocyte stage with a complete absence of spermatids and spermatozoa. This observation led to the hypothesis that hspA2 may be disrupted in human testes with abnormal spermatogenesis. To test this hypothesis, we studied the mRNA expression of hspA2 in infertile men with azoospermia. Design: The mRNA expression were analyzed by competitive RT-PCR among testes with normal spermatogenesis, pachytene spermatocyte arrest, and sertoli-cell only syndrome. Materials and methods: Testicular biopsy was performed in men with azoospermia (n=15). Specimens were subdivided into three groups: (group 1) normal spermatogenesis (n=5), (group 2) spermatocyte arrest (n=5), (group 3) Sertoli-cell only syndrome (n=5). Total RNA was extracted by Trizol reagent. Total extracted RNA was reverse transcribed into cDNA and amplified by PCR using specific primers for hspA2 target cDNAs. A competitive cDNA fragment was constructed by deleting a defined fragment from the target cDNA sequence, and then coamplified with the target cDNA for competitive PCR. Glyceraldehyde-3-phosphate dehydrogenase (GAPDH) gene was used as an internal control. Results: On Competitive RT-PCR analyses for hspA2 mRNA, significant amount of hspA2 expression was observed in group 1, whereas a constitutively low level of hspA2 was expressed in groups 2 and 3. Conclusion(s): The study demonstrates that the hspA2 gene expression is down-regulated in human testes with abnormal spermatogenesis, which in turn suggests that hspA2 gene may play a specific role during meiosis in human testes.

  • PDF

Torsional moment of orthodontic wires (교정용 와이어의 비틀림 모멘트)

  • Choy, Kwangchul;Kim, Kyung-Ho;Park, Young-Chel;Kang, Chang-Soo
    • The korean journal of orthodontics
    • /
    • v.30 no.4 s.81
    • /
    • pp.467-473
    • /
    • 2000
  • As a rectangular wire Is inserted into edgewise brackets the wire exerts a force system three-dimensionally. The force system may include bending force in first and second orders and a torsional force in third order Analytical and experimental studies on bending force have been Introduced, but information about torsion is still lack. The purpose of this study was to estimate the torsional moment in the force system of rectangular arch wires through theoretical and experimental studies. Wires most frequently used for third order control were selected as study materials. Cross sections of 0.016x0.022, 0.017x0.025, 0.019x0.025 inch rectangular wires in foot different materials such as stainless steel(Ormco), TMA(Ormco), NiTi(Ormco), and braided stainless steel (DentaFlex, Dentaurum) were used. The torque/twist rate of each test material was calculated using the torsion formula. Torque/twist rate, yield torsional moment, and ultimate torsional moment were measured with a torque gauge. The torsion formula assesses that the torque/twist rate (T/$\theta$) is proportional to the characteristics of material (G) and cross section (J), and is inversely proportional to the length of wire (L). Most experimental results corresponded with the formula. The relative stiffness was calculated for reference to a logical sequence of wire changes.

  • PDF