• Title/Summary/Keyword: Healthy volunteers

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Clinical Effects of Intake of Juice Valley and Gogu Valley toward Fecal Microflora of Healthy Human Volunteers

  • Lee, Hoi-Seon
    • Food Science and Biotechnology
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    • v.14 no.4
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    • pp.540-542
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    • 2005
  • Juice Valley and Gogu Valley were administered to twelve healthy young volunteers for 4 weeks to study their clinical effects on human intestinal microflora. Changes in fecal microflora, fecal moisture, and fecal pH were observed for Juice Valley intake. Administration of Juice Valley significantly increased numbers of Bifidobacterium and Lactobacillus from 8.69 and 7.02 to 10.89 and 9.02 (Log CFU/g wet feces), respectively, whereas those of Clostridium perfringens and Escherichia coli decreased. Moisture content of feces increased, and fecal pH decreased after 4 weeks of Juice Valley intake, intake of Gogu Valley slightly increased growth responses of Bifidobacterium and Lactobacillus and decreased growth responses of C. perfringens and E. coli. Su-mi potato, as a reference, had no effect on Bifidobacterium and Lactobacillus numbers. This study confirmed Juice Valley has better effects than Gogu Valley and Su-mi, and has important role on growth promotion and inhibition of human intestinal bacteria.

Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Human Volunteers

  • Lee, Jun-Woo;Kim, Sung-Chull;Yoo, An-Na;Chang, Hyun-Sung;Lee, Kyung-Hee;Park, Jong-Min;Nam, Doo-Hyun
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.307.2-308
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    • 2003
  • The bioequivalence of two 12.72 mg domperidone maleate tablets (Sinil “perinal$\^$ⓡ/” tablets vs. Janssen Korea “Motirium-M$\^$ⓡ/” tablets) was assessed in healthy volunteers after oral administration of two tablets in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for domperidone base using a validated HPLC method. (omitted)

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Bioequivalence Study of Loxoprofen Sodium in healthy Volunteers (Loxoprofen sodium 제제(레녹스정)의 생물학적 동등성시험)

  • 최주영;유내춘;박민수;김경환
    • Biomolecules & Therapeutics
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    • v.6 no.4
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    • pp.417-422
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    • 1998
  • Loxoprofen sodium (sodium 2-[4-(2-oxocyclopentylmethyl)phenyl] propionate dehydrate) is a nonsteroidal antiinflammatory drug of $\alpha$-phenyl propionic acid derivative. To test the bioequivalence of loxoprofen, the pharmacokinetic parameters of new preparation of loxoprofen, LENOX was compared with LOXONIN as a reference drug. Fourteen healthy volunteers were entered to the stydy (Yonsei University College of Medicine, Severance Hospital IRB approval No. 9608). They were administered 60 mg of loxoprofen in 2$\times$2 cross-over design. There was one week of drug-free interval between doses. The blood sample was taken on schedule up to 8 hours, and the plasma concentration loxoprofen was measured by reverse phase high-performance liquid chromatography (HPLC) with UV-detector. There were no significant difference between two preparations when AUC, Cmax, and Tmax were compared by ANOVA. The mean differences of AUC, Cmax, and Tmax were within 20% of the reference drug: the values were 2.22,5.61, and 12.50%, respectively. The confidence limits of AUC and Cmax but not Tmax satisfied the bioequivalence criteria. These results suggest that the tested LENOX is bioequivalent to the reference drug.

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BIOEQUIVALENCE EVALUATION OF TIROPRAMIDE HCI 100 MG TABLETS IN HEALTHY MALE KOREAN VOLUNTEERS

  • Lee, Suk;Cho, Hea-Young;Kang, Hyun-Ah;Lee, Yong-Bok
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.420.1-420.1
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    • 2002
  • The purposes of this study were to evaluate bioequivalence (BE) using In-transformed pharmacokinetic parameters obtained from two tiropramide HCI products and to develop the analytical methods for the quantitative determination of tiropramide in human serum. In addition. the in vitro dissolution profiles of the two tiropramide HCI products in various dissolution media: pH 1.2, 4.0. 6.8 and water (KP Ⅶ Apparatus II method) were assessed. BE was evaluated in 20 healthy male Korean volunteers in randomized crossover study. (omitted)

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Bioequivalence Assessment of Shinpoong "$\textrm{Dompi}^{?}$" Tablets Containing Domperidone Maleate in Healthy Korean Volunteers

  • Yoo , An-Na;Kim, Sung-Chul;Lee, Kyung-Hee;Park, Jong-Min;Nam, Doo-Hyun
    • Proceedings of the PSK Conference
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    • 2003.10b
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    • pp.242.1-242.1
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    • 2003
  • The bioequivalence of two tablet formulations of 12.72 mg domperidone maleate (Shinpoong "$\textrm{Dompi}^{?}$" tablets vs. Janssen Korea "$\textrm{Dompi}^{?}$" tablets) was assessed in healthy Korean volunteers after oral administration in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of $AUC_{0{\longrightarrow}48}$, $C_{max}$, $T_{max}$$t\frac{1}{2}$ were determined from plasma concentration-time profile of two formulations. (omitted)

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PK/PD Modeling for Glucose-lowering Effect of Metformin in Korean Volunteers

  • Lee, Shin-Hwa;Yun, Min-Hyuk;Kwon, Kwang-Il
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.307.1-307.1
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    • 2003
  • Metfotrmin is a biguanide antihyperglycemic agent often used for the treatment of non-insulin dependent diabetics(NIDDM). Metformin lowers both fasting and postprandial plasma glucose concentrations by improving insulin sensitivity at hepatic and peripheral tissues. The pharmacokinetics and pharmacodynamics of metformin were studied in Korean healthy volunteers at fasting state over 10 hours. (omitted)

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Pharmacokinetic Study of Levosulpiride Tablets in Human Volunteers

  • Lee, Jung-Min;Yoon, Mi-Kyeong;Lee, Sung-Jae;Kim, Sun-Kyu;Choi, Young-Wook
    • Proceedings of the PSK Conference
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    • 2003.10b
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    • pp.240.3-241
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    • 2003
  • The purpose of this trial was to determine pharmacokinetic parameters and to characterize bioavailability of levosulpiride after oral administration in Korean healthy male volunteers. Thirty subjects were received a single oral dose of a tablet (Isomeric$\^$\ulcorner/) containing 25 mg of levosulpiride. The plasma concentrations of levosulpiride were measured by a validated FLD-HPLC method and compared with those reported in the literature. Levosulpride was absorbed slowly, revealing peak concentrations between 4 and 6 hr after oral administration. (omitted)

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The Agreement in Cold-Heat and Health Status among Sasang Constitutional Experts in Diagnosis of Sasang Pathological Symptoms (사상의학 병증진단에 있어서 사상의학 전문가의 한열 특성 및 건강상태 평가에 관한 일치도 연구)

  • Jin, Hee-Jeong;Kim, Sang-Hyuk;Dong, Sang-Oak;Jang, Eun-Su;Lee, Si-Woo
    • Journal of Sasang Constitutional Medicine
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    • v.26 no.2
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    • pp.146-155
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    • 2014
  • Objectives In Sasang Constitutional medicine(SCM), it is an important factor to assess the degree of cold/heat and healthy status. We purposed to check the agreement among the experts on the assessment of cold/heat and healthy status. Methods Six SCM experts and 10 healthy volunteers were recruited for this study. The SCM experts had an interviewed with each volunteer in the similar condition like that of the actual clinic. And then the expert evaluated each volunteer's cold/heat and healthy status. Intraclass correlation coefficient(ICC) was used to measure the interrater reliability and interrater agreement among the experts. Results Two volunteers are excluded due to the missing data, therefore eight persons' data (3 males and 5 females) were included in our analysis. The mean of age and BMI are 21.73(${\pm}2.32$) and 29.63(${\pm}4.66$), respectively. In health status, cold status and heat status, the ICC was 0.789, 0.904, 0.925, respectively. Conclusions We found that the assessment of cold/heat and healthy status was continued reliable among SCM experts. The assessment of cold/heat status was more consistent than the assessment of healthy status.