• Title/Summary/Keyword: Korean healthy volunteers

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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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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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Effect of Laserneedle Aupuncture Therapy for Mental Stress on Heart Rate Variability (소부(少府)(HT8) 레이저 침 시술이 정신적 스트레스를 가한 성인의 심박변이도에 미치는 영향)

  • Park, Hyun-ChuI;Kang, Mun-Su;Kim, Lak-Hyung
    • Journal of Oriental Neuropsychiatry
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    • v.18 no.3
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    • pp.113-122
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    • 2007
  • The purpose of this study was to evaluate the effects of mental stress measured with heart rate variability(HRV) in healthy adults and to evaluate the effects of laserneedle acupuncture therapy in healthy adults. Methods : 25 healthy volunteers participated in this study. The volunteers were divided randomly, the real laserneedle acupuncture therapy group or the sham laserneedle acupuncture therapy group. First, After 5 minute rest, mental stress was given with stroop color word task and calculation task. And then laserneedle acupuncture therapy or sham laserneedle therapy was done on HT8(少府) for 15 minute. HRV was recorded in 3 period-before stress, after stress, and after laserneedle or sham acupuncture therapy. Results : LF was significantly increased after mental stress. And there was no significant difference between the real laserneedle acupuncture therapy group and the sham laserneedle acupuncture therapy group. Conclusions : This results show that mental stress-stroop color word test and calculation test for 10 minute- contribute to activation of the sympathetic nervous system.

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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 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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Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study (궁하탕정의 단회 경구투여 후 안전성 평가를 위한 단일기관 연구)

  • An, Sung-Hu;Shin, Hee-Ra;Park, Kyungtae;Lee, Yoon-Seung;Kim, Jonggyu;Yeom, Seung-Ryong;Kwon, Young-Dal;Cho, Hea-Young
    • Journal of Korean Medicine Rehabilitation
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    • v.29 no.4
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    • pp.101-108
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    • 2019
  • Objectives The purpose of this study is to evaluate the safety of Gunghatang tablet in healthy male volunteers. Methods Single center pharmacokinetics study was carried out in healthy male volunteers. Through the laboratory test, vital sign and adverse event data, safety evaluation was conducted. Total 15 of 16 subjects who met the inclusion criteria were enrolled and three subjects were allocated to waiting group. 12 subjects were allocated by serial number according to registration order. Subjects took the maximum daily dose of the tablet on the second day of hospitalization. For the evaluation of safety, blood samples were collected and vital sign were checked 4 times (screening, before administration, after administration and follow up period) during the trial. All adverse events were recorded and summarized as frequency and percentage. All continuous data were summarized as mean and standard deviation. For comparison of variables between before administration and after administration, data were analyzed by paired T-test or Wilcoxon signed rank test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, there were no significant differences associated with the clinical trial drug between pre and post administration. And there was no adverse event associated with the clinical trial drug. Conclusions Gunghatang tablet were found to be safe for healthy male volunteers.

The evaluation of effectiveness in the family volunteer management system (가족자원봉사 관리체계의 효과성 연구)

  • Kang, Ki-Jung;Chung, Chun-Seok
    • Journal of Family Resource Management and Policy Review
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    • v.10 no.4
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    • pp.145-161
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    • 2006
  • This research paper represents family volunteer management system for the purpose of activating family volunteer activities. This family volunteer management system is based on the family volunteer activity cases by healthy family support center in Cheon-An City. The following data is the evaluation of effectiveness in the family volunteer management system. 9 families (32 people) among family volunteers who are participated in activities worked for twelve to eighteen hours per a month; one to six times per a month; at the more than two different social welfare facilities. They volunteered in the areas of cultural experience programs for the immigrant's families, baby cares, help for the handicaps and hospice. Family volunteers showed high satisfaction levels; average 4.37 out of 5; in the Family volunteer's management system. They checked in the area of volunteer's training, activity period, activity places, teamwork, healthy family support center, and supervisor of volunteer center.

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A randomized, open labeled study comparing the serum levels of cobalamin after three doses of 500 mcg vs. a single dose methylcobalamin of 1500 mcg in patients with peripheral neuropathy

  • Sil, Amrita;Kumar, Hrishikesh;Mondal, Rahul Deb;Anand, Sidharth Sankar;Ghosal, Anirban;Datta, Ashis;Sawant, Sandesh V;Kapatkar, Vaibhavi;Kadhe, Ganesh;Rao, Sameer
    • The Korean Journal of Pain
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    • v.31 no.3
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    • pp.183-190
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    • 2018
  • Background: Vitamin B12 deficiency has been associated with peripheral neuropathy, loss of sensation in the peripheral nerves, and weakness in the lower extremities. Methylcobalamin is the most effective analogue of vitamin B12 used to treat or prevent the complications associated with vitamin B12 deficiency. The current study aimed to compare the serum cobalamin levels after administration of two different regimes of methylcobalamin in peripheral neuropathy patients. Methods: The present study was a prospective, randomized, comparative study. The study consisted of two parallel groups, group A (methylcobalamin $500{\mu}g$ injection intramuscularly three times a week) and group B (methylcobalamin $1500{\mu}g$ injection intramuscularly once a week). A control group of healthy volunteers was also included. Results: A total of 24 patients (12 in each group) were included in the study. Five healthy volunteers were also included as a control in each group. At the end of treatment, serum cobalamin levels were significantly (P = 0.028) higher in group A ($1892.08{\pm}234.50$) as compared with group B ($1438.5{\pm}460.32$). The serum cobalamin levels in Group A healthy volunteers were also two times higher than that of group B (P = 0.056). Both the LANSS scale and DN4 questionnaire reported similar results at end of treatment. Conclusions: The $500{\mu}g$ methylcobalamin thrice weekly regime is more effective in increasing the serum cobalamin levels as compared to the $1500{\mu}g$ methylcobalamin once weekly regime.

The Change of Biophoton Emission on Acupuncture Stimulus and Environment Condition in Healthy Volunteers (환경조건 및 침자극에 따른 인체 생물 광자 방출량 변화에 관한 연구)

  • Ryu, Yeon-Hee;Jung, Sang-Yong;Hwang, Hye-Suk;Kim, Yoo-Sung;Lee, Young-Seop;Yang, Eun-Jin;Choi, Sun-Mi
    • Korean Journal of Oriental Medicine
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    • v.14 no.2
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    • pp.35-39
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    • 2008
  • Objective: Recently biophysical research has shown very weak radiation of photons in plant, animal and human cells. Biophoton emission of the aliving system has received specific phenomena because of its scientific potential for monitoring metabolism to human body. This paper proposes a new challenge possibility of the biophoton emission in biophysiological human condition index. Method: Biophoton emission were measured with twenty one healthy volunteers. The study analyses existence for the effect of specific acupoint stimulus, exposure to the sun and low temperature in healthy volunteers. Two photomultiplier tubes which spectral range was from 300 nm to 650 nm was used for the detection of biophoton emission observation of possible acupuncture stimulation effect at left hand palm. Result: There was a reversion of relative emission rates from the palms affected the environment condition. Otherwise, when the acupuncture stimulation, the emission rate was not enough significantly change(p<0.05). Conclusion: In this study, biophoton emissions depend on the environment condition for all subjects. Measurments with the biophoton emission rate analysis might be much considered in future studies.

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