• Title/Summary/Keyword: Korean healthy volunteers

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Bioavailability Test of TestoTM Tablets (Methyltestosterone, 25 mg) in Male Healthy Volunteers by a Gas-chromatography/Mass Selective Detector

  • Kwon, Oh-Seung;Kim, Hye-Jung;Pyo, Hee-Soo;Kim, Dae-Duk;Chung, Youn-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.5
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    • pp.383-388
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    • 2005
  • A simple and specific method for determination of methyltestosterone (MT) has been established by a gas chromatography/mass selective detector and applied in plasma of healthy male volunteers received a single oral dose of 50 mg MT $(Testo^{TM}\;tablets,\;25\;mg)$ for bioavailability test. This method involves using liquid-liquid extraction of the sample with diethyl ether and derivatization with MSTFA. MT showed good resolution in this condition. The detection limit of quantitation was 5 ng/ml. A good linearity (r>0.996) was obtained at the range of 5-250 ng/ml of MT. Intra-day precision and accuracy were 2.76-12.56% and 0.39-8.01 %, and inter-day precision and accuracy were 2.29-17.69% and 0.42-7.99%, respectively. The established method was applied on bioavailability test of MT in human volunteers. The value of $AUC_{0\;to\;last}$ to last was $264.5{\pm}123.9\;ng{\cdot}hr/ml$ and that of $AUC_{0\;to\;inf}$ was determined to be $275.2{\pm}126.5\;ng{\cdot}hr/ml$. The values of $C_{max}$ and $T_{max}$ were $95.9{\pm}67.1\;ng/ml$ and $1.13{\pm}0.9\;hr$, respectively. The mean elimination half-life $(t_{1/2})$ was $4.4{\pm}0.9\;hr$. This analytical method is suitable and useful for the pharmacokinetics and bioequivalence studies of MT.

Study in Development and Satisfaction of the Family Volunteer Activity Program: Focused on "Sharing Love and Joy with Growing Sprouts" Program and the Participants (가족자원봉사 프로그램개발과 만족도에 관한 연구: "새싹으로 나누는 사랑, 함께하는 기쁨" 프로그램과 참여자를 중심으로)

  • Kim, Hye-Ryoung;Jung, Min-Ja
    • Journal of the Korean Home Economics Association
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    • v.49 no.2
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    • pp.51-62
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    • 2011
  • The purpose of this study was to develop field programs to activate family volunteering and thereby promote healthy family life. The programs were based on a review of family ecological theories of family volunteering activities. A focus group interview was conducted about satisfaction of the program with five volunteers who were experiencing the same family life cycle. The results of study showed that growing sprouts, which are environmentally friendly activities in family, and family volunteer activities lead to family leisure, table, community sharing cultures and cooperation culture between the family and the community. These effects can ultimately contribute to the creation of a healthy family culture.

Pharmacokinetic Propertiese of Entecavir 1 mg in Korean Healthy Volunteers (건강한 한국인 피험자에서 Entecavir 1 mg 제제의 약동학적 특성 평가)

  • Jeon, Ji-Young;Hwang, Min-Ho;Im, Yong-Jin;Kim, Yun-Jeong;Han, Su-Mi;Im, Sung-Hyuk;Chae, Soo-Wan;Kim, Min-Gul
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.3
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    • pp.224-227
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    • 2011
  • Entecavir is a potent and selective guanosine analogue that has demonstrated a significant antiviral efficacy against hepatitis B virus (HBV). The aim of this study was to evaluate the safety and pharmacokinetic profile after a single dose of entecavir 1 mg administration in Korean healthy male subjects. Eight volunteers were enrolled. After a single dose of 1 mg entecavir was orally administered, blood samples were collected at specific time intervals from 0-168 hours. The plasma concentrations of entecavir were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles. The mean values for $AUC_{last}$ and $AUC_{inf}$ were $14.84{\pm}7.81ng{\cdot}hr/mL$ and $20.71{\pm}8.80ng{\cdot}hr/mL$, respectively. The mean value for $C_{max}$ was $9.19{\pm}4.91ng/ml$ and median value for $t_{max}$ was 0.58 hr. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. The results are suggested to be useful in clinical trials of entecavir in Korean subject including bioequivalence study.

Diversity of Duodenal and Rectal Microbiota in Biopsy Tissues and Luminal Contents in Healthy Volunteers

  • Li, Gangping;Yang, Min;Zhou, Kan;Zhang, Lei;Tian, Lugao;Lv, Shangze;Jin, Yu;Qian, Wei;Xiong, Hanhua;Lin, Rong;Fu, Yu;Hou, Xiaohua
    • Journal of Microbiology and Biotechnology
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    • v.25 no.7
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    • pp.1136-1145
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    • 2015
  • The diverse microbial communities that colonize distinct segments of the gastrointestinal tract are intimately related to aspects of physiology and the pathology of human health. However, most recent studies have focused on the rectal or fecal microbiota, and the microbial signature of the duodenum is poorly studied. In this study, we compared the microbiota in duodenal and rectal samples to illustrate the characteristic microbial signatures of the duodenum in healthy adults. Nine healthy volunteers donated biopsies and luminal contents from the duodenum and rectum. To determine the composition and diversity of the microbiota, 454-pyrosequencing of bacterial 16S rRNA was performed and multiple bioinformatics analyses were applied. The α-diversity and phylogenetic diversity of the microbiota in the duodenal samples were higher than those of the rectal samples. There was higher biodiversity among the microbiota isolated from rectal biopsies than feces. Proteobacteria were more highly represented in the duodenum than in the rectum, both in the biopsies and in the luminal contents from the healthy volunteers (38.7% versus 12.5%, 33.2% versus 5.0%, respectively). Acinetobacter and Prevotella were dominant in the duodenum, whereas Bacteroides and Prevotella were dominant in the rectum. Additionally, the percentage of OTUs shared in biopsy groups was far higher than in the luminal group (43.0% versus 26.8%) and a greater number of genera was shared among the biopsies than the luminal contents. Duodenal samples demonstrated greater biological diversity and possessed a unique microbial signature compared with the rectum. The mucosa-associated microbiota was more relatively conserved than luminal samples.

Effect of Electroacupuncture Stimulation on Heart Rate Variability in Healthy Adults (전침 자극이 정상 성인의 심박변동에 미치는 영향)

  • Kim, Min-su;Kwak, Min-ah;Jang, Woo-seok;Rhie, Ki-tae;Jeong, Kee-sam;Jung, Tae-young;Seo, Jung-chul;Seo, Hae-gyoung;An, Hee-duk
    • Journal of Acupuncture Research
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    • v.20 no.4
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    • pp.157-169
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    • 2003
  • Objective : The effects of electroacupuncture(EA) stimulation on heart rate variability(HRV) for healthy adults are investigated with power spectrum analysis(PSA) of HRV. Methods : The HRVs of every 10 minute for 22 healthy volunteers(13 men and 9 women) were measured for an hour with SA-3000P(Medicore Co., Ltd., Korea). The median age with arithmetic range of 13 men and 9 women was 26.00 years with 22.75~27.00 years. The initial 20 minutes were defined as baseline period(pre-EA period), the following 20 minutes as the EA period and the last 20 minutes as the post-EA period. In each EA periods, volunteers received EA(2Hz, 0.6~0.8ms duration, maximal tolerated stimulation without discomfort) on the right Zusanli(ST36), Shangjuxu(ST37) acupoints while supine, resting. Results : Heart rate of volunteers at post-EA period was significantly decreased compare to that of pre-EA period, while SDNN at post-EA period was significantly increased. Heart rate at EA period was significantly decreased compare to that of pre-EA period, but Ln(LF) and LF/HF at EA period were significantly increased. Ln(HF) at post-EA period was significantly decreased compare to that of EA period, while the other variables were not significantly changed. Conclusions : The results suggest that EA in healthy adults is associated with changed activity in the sympathetic and parasympathetic nervous system. Further study is needed for investigating the effects of EA on HRV and autonomic nervous system.

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Smoking Related DNA Damage in Human Lymphocytes Assessed by the Comet Assay (단세포전기영동법으로 평가한 흡연자의 백혈구 DNA손상)

  • 선수진;정해원;한정호
    • Environmental Mutagens and Carcinogens
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    • v.22 no.2
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    • pp.83-89
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    • 2002
  • The single cell gel electrophoresis (comet) assay is one of the useful tools for the study of genetic damage in humans exposed to environmental mutagens and carcinogens. This study was undertaken to evaluate the status of DNA damage in peripheral lymphocytes depending on their sex, age, smoking habits, and other factors in normal healthy Korean population. The 99 volunteers included in the study and out of these, 36 volunteers were smoker and 63 volunteers were non-smoker aged between 20-59 years. All individual answered a questionnaire that assessed their general information including smoking habits and the extent of the environmental tobacco smoke (ETS) exposure, and blood samples were obtained. There was a statistically significant difference in the extent of DNA damage between smoker and non-smoker (p<0.001). A significant difference was also observed between male and female (p<0.001) and amongst the different group of age (p<0.005), however, correlation analysis showed that only smoking habit was a significant factor for DNA damage. No significant effect of smoking duration, number of cigarettes smoking a day, SPY (smoke pack years) in smokers and environmental tobacco smoke exposure in non-smokers on the status of DNA damage was observed.

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The Effect of an Educational Intervention on Health Literacy and the Adoption of Nutritional Preventive Behaviors Related to Osteoporosis Among Iranian Health Volunteers

  • Dehghankar, Leila;Panahi, Rahman;Hasannia, Elham;Hemmati, Fatemeh;Siboni, Fatemeh Samiei
    • Journal of Preventive Medicine and Public Health
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    • v.54 no.6
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    • pp.404-411
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    • 2021
  • Objectives: Given the increase in osteoporosis among health volunteers and the effect of health literacy on the adoption of nutritional preventive behaviors, this study aimed to determine the effects of an educational intervention on health literacy and the adoption of nutritional preventive behaviors related to osteoporosis among health volunteers. Methods: This was a quasi-experimental, interventional study of health volunteers conducted in 2020. In this study, 140 subjects (70 in both intervention and control groups) were selected using the random multi-stage sampling method. An educational intervention was conducted using the Telegram application, and educational messages were sent to the health volunteers in the intervention group across 6 sessions. Data were collected via a demographic questionnaire, the Health Literacy for Iranian Adults survey, and a nutritional performance questionnaire, which were completed before and 3 months after the intervention. The data were collected and analyzed using SPSS version 23. Results: Before the intervention, there were no significant differences in the mean scores for health literacy variables and the adoption of nutritional preventive behaviors between the intervention and control groups (p>0.05). After the intervention, there was a significant change in the mean scores for health literacy and the adoption of preventive behaviors in the intervention group (p<0.05) as opposed to the control group. Conclusions: Interventions aimed at increasing health literacy are effective for promoting the adoption of preventive and healthy nutritional behaviors related to osteoporosis.

Effect of Red Ginseng on cytochrome P450 and P-glycoprotein activities in healthy volunteers

  • Kim, Dal-Sik;Kim, Yunjeong;Jeon, Ji-Young;Kim, Min-Gul
    • Journal of Ginseng Research
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    • v.40 no.4
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    • pp.375-381
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    • 2016
  • Background: We evaluated the drug interaction profile of Red Ginseng (RG) with respect to the activities of major cytochrome P450 (CYP) enzymes and the drug transporter P-glycoprotein (P-gp) in healthy Korean volunteers. Methods: This article describes an open-label, crossover study. CYP probe cocktail drugs, caffeine, losartan, dextromethorphan, omeprazole, midazolam, and fexofenadine were administered before and after RG supplementation for 2 wk. Plasma samples were collected, and tolerability was assessed. Pharmacokinetic parameters were calculated, and 90% confidence intervals (CIs) of the geometric mean ratios of the parameters were determined from logarithmically transformed data using analysis of variance after RG administration versus before RG administration. Results: Fourteen healthy male participants were evaluated, none of whom were genetically defined as poor CYP2C9, 2C19, and CYP2D6 metabolizers based on genotyping. Before and after RG administration, the geometric least-square mean metabolic ratio (90% CI) was 0.870 (0.805-0.940) for caffeine to paraxanthine (CYP1A2), 0.871 (0.800-0.947) for losartan (CYP2C9) to EXP3174, 1.027 (0.938-1.123) for omeprazole (CYP2C19) to 5-hydroxyomeprazole, 1.373 (0.864-2.180) for dextromethorphan to dextrorphan (CYP2D6), and 0.824 (0.658-1.032) for midazolam (CYP3A4) to 1-hydroxymidazolam. The geometric mean ratio of the area under the curve of the last sampling time ($AUC_{last}$) for fexofenadine (P-gp) was 0.963 (0.845-1.098). Administration of concentrated RG for 2 wk weakly inhibited CYP2C9 and CYP3A4 and weakly induced CYP2D6. However, no clinically significant drug interactions were observed between RG and CYP and P-gp probe substrates. Conclusion: RG has no relevant potential to cause CYP enzyme- or P-gp-related interactions.

Effect of Cimetidine on the Pharmacokinetics of Intraveneous Cyclosporine in Human Subjects (시메티딘 정맥투여가 사이크로스포린의 체내동태에 미치는 영향)

  • Choi, In;Choi, Jun Shik
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.1
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    • pp.19-24
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    • 2000
  • The effect of cimetidine on the pbarmacokinetic parameters of cyclosporine (intravenous administration) were determined in 6 healthy volunteers (22-48 years old, 48-62 kg) by cross-over design. Cyclosporine and cyclosporine metabolites in whole blood were analysed by fluororescence polarization immunoassay (TDx-FLX). The blood concentrations of cyclosporine After pretreatment with cimetidine (200 mg bid, for 3days) were increased significantly at 8-12 hrs compared to the control (p<0.05). The ratios of blood concentrations of cyclosporine metabolites (M1, M17) to parent drug were decreased significantly at 8-12 hrs (p<0.05). Total body clearance (CL) was also decreased significantly (p<0.05), and area under the curve $(AUC,\%)$ was increased but not significant.

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Determination of Clotiazepam in the Plasma Using Gas Chromatography/Mass Spectrometry with an Ion-Trap Detector and its Application to Pharmacokinetics in Healthy Volunteers

  • Kwon, Oh-Seung;Kim, Seung-Yong;Chung, Youn-Bok
    • Journal of Pharmaceutical Investigation
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    • v.36 no.2
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    • pp.123-129
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    • 2006
  • A method determining the plasma concentration of clotiazepam was developed by using gas chromatography/mass spectrometry with an ion-trap detector and was validated for applying pharmacokinetics to human volunteers orally taken 5 mg dose of clotiazepam. The detection limit was 1 ng/ml and the limit of quantitation was 5 ng/mt. Intraday reproducibility and accuracy bias % were less than 8.2 and 10.2% with inter-day variations for those being within 7.0 and 13.8%, respectively. The recovery of clotiazepam was higher than 87%. The principal pharmacokinetic parameters were determined from the plasma concentration-time plot by non-compartmental or two-compartmental analysis. In non-compartmental analysis, the elimination half-life of 10.4 hr and the area under the curve of 651.3 ng hr/ml were determined, and the maximal concentration (158.6 ng/ml) in the plasma was obtained at 0.56 hr post-dose. The developed method can be appropriate to apply pharmacokinetics and bioequivalence of clotiazepam.