• 제목/요약/키워드: healthy volunteers

검색결과 870건 처리시간 0.027초

Bioequivalence Evaluation of Two Atenolol Tablet Preparations in Korean Healthy Male Volunteers

  • Gwak, Hye-Sun;Chun, In-Koo
    • Biomolecules & Therapeutics
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    • 제15권3호
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    • pp.187-191
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    • 2007
  • This study was conducted to compare the bioavailability of two brands of atenolol (50 mg) tablets, which are a generic product of $Ditent^{\circledR}$ (Daewon Pharmaceutical Co., Ltd., Korea) and an innovator product $Tenormin^{\circledR}$ (Hyundai Pharm. Ind. Co., Ltd., Korea), in 20 healthy Korean male volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way cross-over design. The washout period between treatments was 1 week. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs. time curves, the following parameters were compared: area under the plasma concentration-time curve ($AUC_{0-24}$), peak plasma concentration ($C_{max}$), time to reach peak plasma concentration ($T_{max}$), and terminal first order elimination half-life ($t_{1/2}$). No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed $AUC_{0-24}$ and $C_{max}$ values of the two products. The 90% confidence interval for the ratio of the logarithmically transformed AUC and $C_{max}$ values of $Ditent^{\circledR}$ over those of $Tenormin^{\circledR}$ were calculated to be between 0.85 and 1.04, and 0.89 and 1.07, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ group was 3.1 hour, and that in Ditent$^{\circledR}$ group was 3.2 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean values were 5.2 hour in the both products. Based on these results, it was concluded that $Ditent^{\circledR}$ was comparable to $Tenormin^{\circledR}$ in both the rate and extent of absorption, indicating that $Ditent^{\circledR}$ was bioequivalent to the reference product, $Tenormin^{\circledR}$.

Survey of Sonoanatomic Distances For Lumbar Medial Branch Nerve Blocks in Healthy Volunteers

  • Gharaei, Helen;Imani, Farnad;Solaymani-Dodaran, Masoud
    • The Korean Journal of Pain
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    • 제27권2호
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    • pp.133-138
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    • 2014
  • Background: The precise knowledge of anatomy and the region of transverse process (TP) and superior articular processes (AP) and their distance from the skin are important in blocking and treating lumbar facet syndrome. Evaluation of these anatomic distances from 3rd and 5th lumbar vertebrae in both sides and in different body mass index (BMI) in healthy volunteers might improve knowledge of ultrasound (US) lumbar medial branch nerve blocks (LMBB). Methods: Bilateral US in the 3rd and 5th lumbar vertebrae of 64 volunteers carried out and the distance between skin to TP and skin to AP was measured. These distances were compared on both sides and in different BMI groups. The analysis was done using SPSS 11. Analysis of variance was used to compare the means at three vertebral levels (L3-L5) and different BMI groups. P values less than 0.05 were considered statistically significant. The paired t-test was used to compare the mean distance between skin to TP and skin to AP on both sides. Results: The distance between skin to TP and skin to AP of 3rd vertebrae to 5th vertebrae was increased in both right and left sides (P < 0.001) from up to down. The mean distance from skin to TP were greater on the left side compared to the right in all three vertebral levels from L3 to L5 (P values 0.014, 0.024, and 0.006 respectively). The mean distance from skin to TP and the skin to AP was statistically significant in different BMI groups (P < 0.001). Conclusions: We found many anatomic distances which may increase awareness of US guided LMBB.

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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    • 제25권7호
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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.

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

  • 김민수;곽민아;장우석;이기태;정기삼;정태영;서정철;서해경;안희덕
    • Journal of Acupuncture Research
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    • 제20권4호
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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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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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    • 제54권6호
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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.

Lipid Peroxidation and Antioxidant Vitamin Status in Oral Cavity and Oropharyngeal Cancer Patients

  • Marakala, Vijaya;Malathi, M.;Shivashankara, A.R.
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권11호
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    • pp.5763-5765
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    • 2012
  • Background: This study was conducted to determine levels of lipid peroxidation and antioxidant vitamin status in patients with oral cavity and oropharyngeal cancer. Methods: The study group consisted of a total number of 80 subjects between the age 40-68 years, 40 with clinically and histopathologically proved cases of oral cavity and oropharyngeal cancer and 40 normal healthy, age and sex matched volunteers as controls. Levels of lipid peroxidation products as malondialdehyde (MDA) and antioxidant vitamins as vitamin A and vitamin C were estimated and compared between the two groups. Results: There was a statistical significant difference in the mean MDA, plasma vitamin A and vitamin C in the oral and oropharyngeal cancer patients compared with the healthy controls (p<0.0001). Conclusions: Lipid peroxidation (MDA) is higher and plasma antioxidant vitamins like vitamin A and vitamin C were lower in oral cavity and oropharyngeal cancer patients than healthy controls.

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

  • 김혜령;정민자
    • 대한가정학회지
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    • 제49권2호
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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.

Risperidone pharmacokinetics in relation to CYP2D6 and MDR1 in healthy male Korean subjects

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Suk;Baek, Seung-Hee;Lee, Yong-Bok
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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    • pp.238.2-239
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    • 2003
  • The purposes of this study were to evaluate the relationship between the genetic polymorphisms in CYP2D6*10 allele, MDR1 (exon 21 and 26) gene and risperidone pharmacokinetics in healthy male Korean subjects. A single dose of 2 mg risperidone tablet was given orally to 23 healthy male Korean volunteers. Blood samples were taken during the 12 hours after the dose. Serum concentrations of risperidone and 9-hydroxyrisperidone were measured using HPLC with UV detector. 23 subjects were genotyped for CYP2D6*10 allele, MDR1 G2677 T and C3435T by polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP). (omitted)

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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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    • 제36권2호
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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.

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

  • 선수진;정해원;한정호
    • 한국환경성돌연변이발암원학회지
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    • 제22권2호
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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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