• 제목/요약/키워드: Tablet

검색결과 1,049건 처리시간 0.026초

로메프록사신 정의 생물학적 동등성 평가 (Bioequivalence Evaluation of Lomefloxacin Tablets)

  • 배준호;박은석;지상철
    • 한국임상약학회지
    • /
    • 제7권2호
    • /
    • pp.67-72
    • /
    • 1997
  • The bioequivalence of two lomefloxacin tablets was evaluated in 16 normal male volunteers (age $21\sim30$ yrs) following oral administration. Test product was 'Lomaxacin tablet' made by Kolon Pharmaceutical Co. and reference product was 'Maxaquin tablet' made by Searle Ciba-Geigy Korea Co. After one tablet containing 400 mg of lomefloxacin was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was determined with an HPLC method using fluorescence detector. AUC, $C_{max},\;and\;T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max},\;and\;T_{max}$ between two products were $0.90\%,\;1.09\%,\;and\;2.44\%$, respectively. The powers (1-${\beta}$) for AUC, $C_{max},\;and\;T_{max}\;were\;>95\%,\;>95\%,\;and\;93.8\%$, respectively Detectable differences $(\Delta)$ and confidence intervals were all less than $20\%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Lomaxacin tablet' is bioequivalent to 'Maxaquin tablet'.

  • PDF

나부메톤 정의 생물학적 동등성 평가 (Bioequivalence of Nabumetone Tablets)

  • 이윤석;박은석;지상철
    • Journal of Pharmaceutical Investigation
    • /
    • 제27권3호
    • /
    • pp.207-212
    • /
    • 1997
  • The bioequivalence of two nabumetone tablets was evaluated in 16 normal male volunteers $(age\;21{\sim}30\;yrs)$ following oral administration. Test product was 'Nacton tablet' made by Jin Yang Pharmaceutical Co. and reference product was 'Unimeton tablet' made by Dong Kwang Pharmaceutical Co.. After one tablet containing 500 mg of nabumetone was administered, blood was taken at predetermined time intervals and the concentration of 6-methoxy-2-naphthylacetic acid, active metabolite of nabumetone, in plasma was determined with an HPLC method using fluorescence detector. AUC, $C_{max}$ and $T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max}$ and $T_{max}$ between two products were 3.66%, 6.87% and 1.85%, respectively. The powers$(1-{\beta})$ for AUC, $C_{max}$ and $T_{max}$ were 91.4%, 88.9% and 81.1%, respectively. Detectable differences$({\Delta})$ and confidence intervals were all less than 20%. All of these parameters met the criteria of FDA for bioequivalence, indicating that "Nacton tablet" is bioequivalent to 'Unimeton tablet'.

  • PDF

아펜탈정의 생물학적 동등성 평가 (Bioequivalence Evaluation of Aceclofenac Tablets)

  • 배준호;최경업;지상철;박은석
    • 한국임상약학회지
    • /
    • 제9권1호
    • /
    • pp.44-48
    • /
    • 1999
  • The bioequivalence of two aceclofenac tablets was evaluated in 14 normal volunteers (age $21\sim29$ yrs) following oral administration. The test product was 'Apental tablet' made by Asia Pharmaceutical Co. and the reference was 'Airtal tablet' made by Daewoong Pharmaceutical Co. After one tablet containing 100 mg aceclofenac was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was quantitated with an HPLC method. AUC, $C_{max}\;and\;T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max}\;and\;T_{max}$ between two products were $4.23\%,\;2.15\%\;and\;0\%$, respectively. The powers for AUC,$\;C_{max}\;and\;T_{max}\;were\;>90\%,\;>90\%\;and\;85.8\%$, respectively. Confidence intervals were within $\pm20\%$ for three parameters. All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Apental tablet' is bioequivalent to "Airtal tablet".(Kor. J. Clin. Pharm. 1999; 9(1): 44-48)

  • PDF

조프란 정(온단세트론 8mg)에 대한 온프란 정의 생물학적동등성 (Bioequivalence of Onfran Tablet to Zofran Tablet (Ondansetron 8mg))

  • 신인철;홍정욱;박윤영;고현철
    • Biomolecules & Therapeutics
    • /
    • 제11권1호
    • /
    • pp.58-64
    • /
    • 2003
  • Ondansetron is a potent, highly selective 5-hydroxytryptamin $e_3$(5-H $T_3$) receptor-antagonist, for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiography, and the treatment of post-operative nausea and vomiting. The purpose of the present study was to evaluate the bioequivalence of two ondansetron tablets, Zofran (Glaxo Smithcline Korea Ltd.) and Onfran (Korea United Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 24.39$\pm$1.69 year in age and 69.00$\pm$6.74kg in body weight, were divided into two groups and a randomized 2${\times}$2 cross-over study was employed. After one tablet containing 8mg of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in plasma were determined using HPLC with UV detector. Pharmacokinetic parameters such as AVC, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC, $C_{max}$ and T max between two tablets were 5.83%, 5.75% and -5.71%, respectively when calculated against the Zofran, tablet. The powers (1-$\beta$) for AUC, $C_{max}$ and $T_{max}$ were above 90%, above 90% and below 60%, respectively. Minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 were less than 20% (e.g., 12.74% and 11.78% for AUC and $C_{max}$ respectively). But minimum detectable differences($\Delta$) at alpha=0.1 and 1-$\beta$=0.8 for $T_{max}$ were more than 20% (e.g., 34.22%). The 90% confidence intervals were within $\pm$20% (e.g., -2.73∼14.39 and -2.16∼13.67 for AUC and $C_{max}$ respectively). But 90% confidence intervals for $T_{max}$ were not within $\pm$20% (e.g., -28.71∼17.28). Another ANOVA test was conducted for logarithmically transformed AUC and $C_{max}$. These results showed that there are no significant difference in AUC and $C_{max}$ between the two formulations: The differences between the formulations in these log transformed parameters were all for less than 20% (e.g., 5.83% and 5.75% for AUC and $C_{max}$ respectively). The 90% confidence intervals for the log transformed data were the acceptance range of log 0.8 to log 1.25 (e.g., log 0.99∼log 1.15 and log 0.98∼log 1.15 for AUC and $C_{max}$ respectively). The major parameters, AUC and $C_{max}$, met the criteria of KFDA for bioequivalence although $T_{max}$ did not meet the criteria of KFDA for bioequivalence, indicating that Onfran tablet is bioequivalent to Zofrm1 tablet.t is bioequivalent to Zofrm1 tablet.m1 tablet.m1 tablet.m1 tablet.

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

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
    • /
    • 제41권5호
    • /
    • 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
    • /
    • 제41권2호
    • /
    • 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.

뉴로메드정(옥시라세탐 800 mg)에 대한 뉴라세탐정의 생물학적동등성 (Bioequivalence of Neuracetam Tablet to Neuromed Tablet (Oxiracetam 800 mg))

  • 최성업;김종석;윤미경;김정일;박석;한상범;이재휘;최용욱
    • Journal of Pharmaceutical Investigation
    • /
    • 제34권3호
    • /
    • pp.215-222
    • /
    • 2004
  • The purpose of the present study was designed to evaluate the bioequivalence of two oxiracetam tablets, Neuromed tablet (Korea Drug Co., reference drug) and Neuracetam tablet (Sam Jin Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Release of oxiracetam from the tablet 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-four healthy volunteers, $23.7\;{\pm}\;2.4$ year in age and $68.9\;{\pm}\;6.2$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 800 mg of oxiracetam, blood samples were taken at predetermined time intervals and concentrations of oxiracetam in plasma were determined using HPLC-MS-MS. The dissolution profiles of two formulations were very similar at all dissolution media. In addition, 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 $AUC_t$ and $C_{max}$ untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug were 0.42%, 0.45% and -12.58% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.94{\sim}log1.06$ and $log0.90{\sim}log1.07$ for $AUC_t$, and $C_{max}$, respectively), indicating that Neuracetam tablet is bioequivalent to Neuromed tablet. The major pharmacokinetic parameters, $AUC_t$, and $C_{max}$ met the criteria set by KFDA for bioequivalence indicating that Neuracetam tablet is bioequivalent to Neuromed tablet.

스마트 미디어 이용동기가 애플리케이션의 이용에 미치는 영향에 대한 연구 (A study on the effect of motivations for using smart media on using application)

  • 최민재
    • 한국언론정보학보
    • /
    • 제61권
    • /
    • pp.52-73
    • /
    • 2013
  • 이 연구의 목적은 스마트폰과 태블릿PC의 이용동기가 애플리케이션 이용에 미치는 영향을 확인하고 플랫폼 간의 차이를 비교해 보기 위한 것이다. 이를 위해 스마트폰 이용자와 태블릿PC 이용자를 대상으로 서베이를 실시했다. 연구결과, 스마트폰과 태블릿PC의 이용동기는 정보를 얻거나, 소통을 하거나, 스마트 미디어의 특정 기능을 사용하거나, 휴식하기 위해 이용되는 등 4가지 차원으로 구성됐다. 이용동기 측면에서 스마트폰 이용자는 스마트폰이 가지고 있는 특정 기능을 이용하는 데 더 치중했으며, 태블릿PC 이용자는 휴식을 위해 이용하는 데 더 치중했다. 그리고 애플리케이션 이용에서는 개별 애플리케이션 유형별로 이용되는 정도가 다른 것이 확인됐다. 스마트폰에서는 정보나 엔터테인먼트 유형의 애플리케이션보다는 커뮤니케이션 유형이 상대적으로 더 많이 이용됐으며, 태블릿PC에서는 커뮤니케이션 유형의 애플리케이션보다는 엔터테인먼트나 정보 유형이 더 많이 이용됐다. 한편 스마트폰의 이용동기와 태블릿PC의 이용동기는 애플리케이션 이용에 부분적으로 강력한 영향을 미치고 있는 것으로 나타났다. 스마트폰과 태블릿PC의 이용동기는 애플리케이션을 이용하게끔 하는 추동력으로서 작용했다. 특히 스마트폰의 이용동기는 개별 애플리케이션의 이용 여부와 정적 관계가 높게 나타났다.

  • PDF

반응표면 분석에 의한 김치 타블렛 부재료의 혼합조건 연구 (Studies on Mixing Conditions of Sub-ingredients of Kimchi Tablet by Response Surface Methodology)

  • 박석란;김미경;황성희;윤광섭;김순동
    • 한국식품저장유통학회지
    • /
    • 제9권3호
    • /
    • pp.298-303
    • /
    • 2002
  • 김치타블렛의 영양성과 기호성을 개선하기 위하여 부재료로 유자, 사과, 당근, 표고버섯의 혼합조건을 반응표면분석법으로 검토하였다. 당근분말은 0.75 g 첨가시에 타블렛의 견고성이 낮았으며, 표고버섯은 첨가량이 증가할수록 견고성이 증가하였다. 사과는 1.0 g 이상으로 첨가될 경우, 표고버섯 및 당근의 첨가량이 견고성에 미치는 영향은 크지 않았다. 김치 타블렛의 hue angle은 유자, 사과, 당근 및 표고버섯의 첨가량이 0.5 g 이하 및 1.0 g 이상일 때는 83∼86, 0.75 g로 첨가하였을 패는 88을 나타내었다. 인공담즙액에서의 용해도는 당근의 경우는 큰 영향이 없었으며 표고버섯은 1.0 g, 사과는 0.75 g 첨가구에서 용해성이 높았다. 타블렛의 종합적 기호도는 사과와 당근의 첨가량이 높을수록, 표고버섯은 0.75 g에서 높았다. 각 반응변수에 미치는 독립변수의 영향을 조사한 결과 당근만이 김치 타블렛의 hue angle에 영향을 미칠 뿐 그 외 다른 부재료는 반응변수에 대하여 큰 영향이 없는 것으로 나타났다. 따라서 당근, 사과 및 표고는 0.75 g을 중심으로 폭넓은 첨가가 가능하였다.

아달라트오로스정에 대한 한미니페디핀서방정의 생물학적 동등성 평가 (Bioequivalence of Hanmi Nifedipine SR Tablet to Adalat Oros Tablet)

  • 고인자;지상철
    • 한국임상약학회지
    • /
    • 제14권2호
    • /
    • pp.78-84
    • /
    • 2004
  • Nifedipine, one of calcium channel antagonists, has been used for the treatment of mild to moderate hypertention, angina pectoris, Raynaud's phenomenon and various other cardiovascular diseases. Because of its short biological half-life, several sustained-release (SR) formulations of nifedipine have been developed. and used clinically. The bioequivalence of the two nifedipine SR preparations was evaluated according to the guidelines of KFDA. The test product was Hanmi Nifedipine SR $tablet^{(R)}$ made by Hanmi Pharm. Co. and the reference was Adalat Oros $tablet^{(R)}$ made by Bayer Korea. Thirty healthy male subjects were divided into two groups and a randomized $2\times2$ cross-over study was employed. After one SR tablet containing 33 mg of nifedipine was orally administered, blood sample was taken at predetermined time intervals and the concentrations of nifedipine in plasma were determined using a validated HPLC method with UV detector. Two pharmacokinetic parameters, $AUC_t\;and\;C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The $90\%$ confidence intewals of the $AUC_t\;and\;the\;C_{max}\;were\;log\;0.81\sim1og\;1.19\;and\;log\;0.84\sim\;log\;1.13,\;respectively.$ These values were within the acceptable bioequivalence intervals from log 0.8 to log 1.25 in KFDA guidelines. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Nifedipine SR tablet is bioequivalent to Adalat Oros tablet.

  • PDF