• Title/Summary/Keyword: Crossover study

Search Result 509, Processing Time 0.025 seconds

Bioequivalence of Cefaclor Monohydrate 250mg Capsules Using an Improved HPLC Analytical Method (개선된 HPLC분석법을 이용한 세파클러 모노하이드레이트 250 mg 캡슐의 생물학적동등성)

  • Kim, Tae-Wan;Cao, Qing-Ri;Han, Sun-Young;Song, Ok-Kyoung;Sin, Kwan-Seog;Kang, Sung-Ha;Lee, Beom-Jin
    • Korean Journal of Clinical Pharmacy
    • /
    • v.15 no.1
    • /
    • pp.21-26
    • /
    • 2005
  • A bioequivalence study of CKD $Cefaclor^{(R)}$ capsule (Chong Kun Dang Pharm Co., Ltd) to $Ceclor^{(R)}$ capsule (Lilly Korea Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the cefaclor dose of 250 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. An improved high-performance liquid chromatorgraphy (HPLC) analytical method with UV detection was used to determine plasma cefaclor concentration in human volunteers for 8 hr after oral drug administration. The area under the plasma concentration-time curve from time zero to 8 hr ($AUC_{0-8hr}$) was calculated by the linear trapezoidal rule. the $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_{0-8hr}\;and\;C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The $90{\%}$ confidence intervals of the $AUC_{0-8hr}$ ratio and the $C_{max}$ ratio for CKD $Cefaclor^{(R)}$ and $Ceclor^{(R)}$ were $0.9400{\leq}{\delta}{\leq}1.0345$ and $0.8858{\leq}{\delta}{\leq}1.1021$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the of CKD $cefaclor^{(R)}$ capsule was bioequivalent to $Cefaclor^{(R)}$ capsule with respect to its bioavailability.

  • PDF

Bioavailability of Cefaclor Capsules Using an Improved Analytical Method of Cefaclor in Human Plasma (개선된 사람 혈장중 세파클러 농도 정량법을 이용한 세파클러 캡슐의 생체이용률 측정)

  • Kim, Tae-Wan;Song, Ok-Kyoung;Han, Sun-Young;Cao, Qing-Ri;Park, Mi-Jin;Kang, Sung-Ha;Shin, Kwan-Seog;Cui, Jing-Hao;Lee, Beom-Jin
    • Journal of Pharmaceutical Investigation
    • /
    • v.35 no.2
    • /
    • pp.117-122
    • /
    • 2005
  • After establishing improved HPLC analytical method of cefaclor in human plasma samples, a bioavailability study of cefaclor capsules was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). The standard calibration curve using an HPLC with UV detector was constructed in a range of $0.0324{\sim}16\;{\mu}g/ml$. The 6% perchloric acid instead of 6% trichloroacetic acid was used to precipitate plasma protein. The HPLC chromatograms were precisely and accurately resolved when spiked with human plasma spiked with cefaclor and cephalexin (internal standard). Twenty healthy male Korean volunteers received two commercial cefaclor capsules, $Neocef^{\circledR}$ capsule (Jinyang Pharm. Co., Ltd) or $Ceclor^{\circledR}$ capsule (Lilly Korea. Co., Ltd.) at the 250 mg cefaclor in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of cefaclor were monitored for 8 hours after oral drug administration. $AUC_t$ the area under the plasma concentration-time curve from time zero to 8 hr (13 points), was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Neocef^{\circledR}/Ceclor^{\circledR}$ were $0.9049{\leq}{\delta}{\leq}1.226$, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Neocef^{\circledR}/Ceclor^{\circledR}$ with respect to the extent of absorption.

Bioequivalence of Traline Tablet to Zoloft® Tablet (Sertraline HCI 50 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.5
    • /
    • pp.317-322
    • /
    • 2011
  • Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. 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 computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% 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 log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

Bioequivalence of Hana Loxoprofen Sodium Tablet to Dongwha Loxonin® Tablet (Loxoprofen Sodium 60 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • v.41 no.2
    • /
    • pp.117-123
    • /
    • 2011
  • Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. 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 computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% 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 log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

Bioequivalence of RoxithrinTM Tablet to RulidTM Tablet (Roxithromycin 150 mg) (루리드 정(록시스로마이신 150 mg)에 대한 록시스린 정의 생물학적동등성)

  • Joung, Sun-Koung;Lee, Yun-Young;Cho, Tae-Seob;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Kyung-Ryul;Lee, Hee-Joo
    • Journal of Pharmaceutical Investigation
    • /
    • v.34 no.3
    • /
    • pp.209-214
    • /
    • 2004
  • A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of Etodin Capsule to Kuhnillodin Capsule (Etodolac 200 mg) (건일로딘 캡슐(에토돌락 200mg)에 대한 에토딘 캡슐의 생물학적동등성)

  • Lee, Myung-Jae;Kang, Jong-Min;Choi, Sang-Jun;Lee, Jin-Sung;Tak, Sung-Kwon;Seo, Ji-Hyung;Rew, Jae-Hwan;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
    • /
    • v.38 no.6
    • /
    • pp.421-427
    • /
    • 2008
  • The purpose of the present study was to evaluate the bioequivalence of two etodolac capsules, Kuhnillodin capsule (Kuhnil. Co., Ltd., Seoul, Korea) as reference drug and Etodin capsule (Myungmun Pharm. Co., Ltd., Seoul, Korea) as test drug, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-three healthy male Korean volunteers received one capsule at the dose of 200 mg etodolac in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of etodolac were monitored by a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 24 hr after the administration. $AUC_{0-24\;hr}$ was calculated by the linear trapezoidal rule method. $C_{max}$ and $T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_{0-24\;hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-24\;hr}$ ratio and the $C_{max}$ ratio for Etodin/Kuhnillodin were $\log\;0.97{\sim}\log\;1.08$ and $\log\;0.89{\sim}\log\;1.19$, respectively. These values were within the acceptable bioequivalence intervals of $\log\;0.80{\sim}\log\;1.25$. Thus, our study demonstrated that Etodin was bioeqiovalent to Kuhnillodin preparation when the rate and extent of absorption between two preparations were compared.

A Study on the Mods-Look Expressed on the 21st Century Fashion (21세기 패션에 표현된 모즈 룩 연구)

  • Chu, Mi-Kyung;Kim, Soon-Ja
    • Journal of the Korean Society of Clothing and Textiles
    • /
    • v.32 no.6
    • /
    • pp.859-870
    • /
    • 2008
  • The purpose of this study is to investigate the fashion reflecting the aesthetic consciousness of a generation and age spirit and to study Mods-Look aesthetically by analyzing how Mods-Look expressed on the fashion magazines(Collezioni Donna) from 2001 to 2006 developed into a new form. 1960's Mods-Look appeared in the well known collections such as New York, Paris, Milan in the form of crossover or with a changed style. Especially after 2000's, in addition to the British fashion, even a new word Mods Story was created to prominently express the free style of the Mods spirit. The expressive characteristics represent 1) minimal style, 2) sports casual style, 3) vintage style, 4) dandy & androgynous style. In conclusion, Mods-Look in 21st fashion used to be street fashion started from minority subculture after world war II, but now suit of that time, geometrical pattern and sensibility are becoming design sources for the various fashion market from high fashion to sports look. Therefore, as young people are becoming the center of society in new millenium, sensibility of that time will be reinterpreted to design and Mods-Look will not be limited to subculture but reflected in design development fulfilling people's taste and new future fashion sense by compromising the past and new trend.

An Convergence Study of the Factors Affecting the Knowledge Level of Dental Health Insurance for Some Dental Workers (일부 치과 종사자의 치과 건강보험의 지식수준에 미치는 요인에 대한 융합연구)

  • Lee, Sun-Mi;Son, Hwa-Kyung
    • Journal of the Korea Convergence Society
    • /
    • v.12 no.10
    • /
    • pp.137-144
    • /
    • 2021
  • The purpose of this study is to analyze the factors affecting the education experience, education needs, and knowledge level of calculation criteria for dental workers. It was conducted on dental workers in Daegu and Gyeongbuk province and an online survey was conducted using Google Survey. We used frequency analysis, crossover analysis, and ANOVA analysis method to find out general characteristic, education experience, education needs, and knowledge level according to education experience and education needs of candidates. As a result of in the knowledge level survey of dental health insurance, there were high rates of incorrect answers to the calculation criteria when the claim program automatically processes it or notifies you through an error window. The level of knowledge of candidates who are experienced, on a claim, and with experience in dental insurance training in the last six months was high. In conclusion, it seems that accurate and correct insurance claims are possible when the dental workers are familiar with the calculation criteria changed through regular dental health insurance education. We look forward to this study providing basic data in preparation of education system for professional dental insurance claims for dental workers.

The Effects of Active Movement Myofascial Decompression Therapy and Static Myofascial Decompression Therapy on Range of Motion, Muscle Strength, Functional Movement in Young Adults. (젊은 성인에서 능동 움직임을 결합한 근막감압치료 적용과 정적 적용이 관절가동범위, 근력, 기능적 움직임에 미치는 영향)

  • Lee, Jee-Hyun;Kim, Tae-Hyeon;Kang, Si-Yun;Kum, Do-Gun;Lee, Sung-Yeon;Do, Kwang-Sun;Kim, Chang-Sook;Bae, Ju-Han;Park, Jun-Hyuck;Kim, Jae-Eun
    • Journal of The Korean Society of Integrative Medicine
    • /
    • v.9 no.3
    • /
    • pp.165-173
    • /
    • 2021
  • Purpose : Myofascial decompression is frequently mentioned as a method applied to cupping. The purpose of this study is to evaluate and compare active range of motion (AROM), muscle strength, and functional movement by applying myofascial decompression to the hamstrings. Methods : This study evaluated AROM, muscle strength, and functional movement by applying active movement myofascial decompression and static myofascial decompression to the dominant leg, respectively, in a crossover design conducted with normal adults (n=21) in their average 20s enrolled at G University in G city, Gyeongsangbuk-do. Active movement myofascial decompression was implemented for five minutes at a rate of 100 bpm to make the beats in flexion and extension respectively. Static myofascial decompression was only performed for five minutes while at rest. All of these interventions were performed at a cupping depth of two mm. After a one-week washout period, static was applied again to compare the same dependent variables. Results : Regarding AROM and muscle strength, both groups showed significant differences in the before and after results (p<.05). However, in the Functional Reach Aspect and Single Leg Hop test, the active movement myofascial decompression group showed better results. There was no statistical difference between the Active movement myofascial decompression group and Static myofascial decompression group in any dependent variable (p<.05). Conclusion : As a result of this experiment, both active movement myofascial decompression and static myofascial decompression had a positive effect on dependent variable. Therefore this study is meaningful in that it is easier and simpler to see the effect on flexibility, muscle strength, and functional movement just by implementing movement myofascial decompression.

Selection of Appropriate Location for Civil Defense Shelters Using Genetic Algorithm and Network Analysis (유전자 알고리즘과 네트워크 분석을 활용한 민방위 대피시설 위치 선정)

  • Yoo, Suhong;Kim, Mi-Kyeong;Bae, Junsu;Sohn, Hong-Gyoo
    • Journal of the Korean Society of Surveying, Geodesy, Photogrammetry and Cartography
    • /
    • v.36 no.6
    • /
    • pp.573-580
    • /
    • 2018
  • Various studies have been conducted to analyze the location appropriateness and capacity of shelters. However, research on how to select new shelters is relatively insufficient. Since the shelter is designated in case of emergency, it is also necessary to efficiently select the location of the shelter. Therefore, this study presented a method for selecting the location of the shelter using network analysis that has been used to analyze the location appropriateness of shelters and genetic algorithm which is a representative heuristic algorithm. First, the network analysis using the existing civil defense evacuation facility data was performed and the result showed that the vulnerability of evacuation has a high deviation by region in the study area. In order to minimize the evacuation vulnerable area, the genetic algorithm was designed then the location of new shelters was determined. The initial solution consisting of candidate locations of new shelters was randomly generated and the optimal solution was found through the process of selection, crossover, and mutation. As a result of the experiment, the area with a high percentage of the evacuation vulnerable areas was prioritized and the effectiveness of the proposed method could be confirmed. The results of this study is expected to contribute to the positioning of new shelters and the establishment of an efficient evacuation plan in the future.