• 제목/요약/키워드: human volunteers

검색결과 395건 처리시간 0.027초

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

  • 최인;최준식
    • 한국임상약학회지
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    • 제10권1호
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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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New Analytical Method of Cyclosporine A in Human Serum by High -performance Liquid Chromatography/Diode Array Detector and Its Application to Pharmacokinetics of Cyclosporine A in Human Volunteers

  • Kim, Eun-Young;Chung, Yeon-Bok;Kwon, Oh-Seung
    • 대한약학회:학술대회논문집
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    • 대한약학회 2002년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2
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    • pp.423.1-423.1
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    • 2002
  • A simple. specific and sensitive method for the determination of cyclosporine A (CsA) in human serum has been developed by a high performance liquid chromatography/diode array detector (DAD) and applied to pharmacokinetic study of CsA. This method involves the use of solid phase extraction procedure following rapid protein precipitation with zinc sulphate from 1 $m\ell$ of human serum, using a disposable $C_{18}$ extraction cartridge. (omitted)

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건강한 성인 지원자를 대상으로 한 필로칼핀 저작정의 타액분비 유도 및 타액중 용출패턴 평가 (Evaluations on Salivary Flow Induction and Dissolution Patterns in Saliva of Pilocarpine Chewing Tablet in Healthy Human Volunteers)

  • 박경호
    • Journal of Pharmaceutical Investigation
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    • 제27권4호
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    • pp.331-335
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    • 1997
  • Xerostomia is caused by organic or functional changes affecting the salivary system at different levels. Patients suffering from xerostomia may also complain of an oral burning sensation, ulceration or soreness, difficulty in swallowing, and poor denture retention. And pilocarpine is administered orally to induce salivary secretion. In Seoul National University Hospital(SNUH) pharmacy, the pilocarpine chewing tablets are prepared and supplied to patients of xerostomia in request of the dental hospital in SNUH. And we tested the salivary flow induction and the dissolution patterns of these products in saliva by a double-blind, sequential cross-over trials to eight healthy human volunteers with placebo. The pilocarpine chewing tablet contained 5 mg of pilocarpine, and placebo consisted of same materials as test drug, but didn't contain pilocarpine. In vivo experiment, all subjects were instructed to chew as 60-80 times/min. Mixed saliva was collected in the ranges of intervals such as 0-2, 2-5, 5-10, 10-15, 15-20, 20-30, 30-45 and 45-60 min after pilocarpine chewing tablet or placebo administration. Saliva volume was measured in each collecting time interval, and saliva pilocarpine concentrations were determined by reversed phase HPLC. The 82.5 percent $(4.13{\pm}0.69\;mg)$ of pilocarpine was extracted from chewing tablets during mastication of 60-80 times per minute for 60 minutes. Among these dissolved amounts, 90 percent was extracted within 20 minutes. The salivary flow rates were more increased in a group who administered pilocarpine chewing tablet at the interval of 5-10, 10-15, 20-30 and 45-60 min rather than a placebo-group, but only extracted amount of pilocarpine at 45-60 min interval is significanly different between two groups (p<0.05). But total amounts of saliva secreted for 1 hour in two group-pilocarpine and placebo treated- were $46.36{\pm}9.72\;ml\;and\;39.09{\pm}7.81\;ml$, respectively, and were not significantly different between two groups.

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

  • 류연희;정상용;황혜숙;김유성;이영섭;양은진;최선미
    • 한국한의학연구원논문집
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    • 제14권2호
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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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휴대폰 전자파가 인체의 시각 자극 반응에 미치는 영향 (The Effects of Electromagnetic Field Emitted by Cellular Phone on Cognitive Function in Human)

  • 김재성;유창용;김수찬;오학태;육재림;김덕원
    • 한국전자파학회논문지
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    • 제14권6호
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    • pp.606-615
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    • 2003
  • 본 연구에서는 일상생활에서 사용하는 휴대폰에서 방출되는 전자파가 인체의 시각 자극 반응에 미치는 영향을 연구하였다. 기존의 국외연구에서는 현재 국내에서 사용되고 있지 않는 아날로그 방식 또는 GSM 방식의 휴대폰을 사용한 연구였으나 본 연구에서는 현재 국내에서 사용되고 있는 CDMA 방식의 휴대폰을 사용하여 시각 자극 반응에 미치는 영향을 평가하였다. 실험은 청소년 집단(10명, 연령:14.3$\pm$1.1세)과 성인 집단(10명, 연령:24.5$\pm$3.4세)으로 구성된 20명의 지원자를 대상으로 실시하였다. 전자파 노출은 실제 휴대폰을 사용하여 이루어졌고, 실제 노출과 허위 노출의 순서에 따른 영향을 없애기 위해 blind test로 노출 순서를 교번시켜서 대등하게 하였다. 실험 결과 CDMA휴대폰에서 방출되는 전자파에 노출되었을 경우 기존의 연구(아날로그 및 GSM방식)에서 제시하는 바와 같이 청소년의 경우에는 자극 반응 속도가 노출군에서 유의하게 빨라짐을 관찰하였다.

Enantioselective Pharmacokinetics of Carvedilol in Human Volunteers

  • Phuong, Nuyen-Thi;Lee, Beam-Jin;Choi, Jung-Kap;Kang, Jong-Seong;Kwon, Kwang-il
    • Archives of Pharmacal Research
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    • 제27권9호
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    • pp.973-977
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    • 2004
  • Carvedilol is administered as a racemic mixture of the R(+)- and S(-)-enantiomers, although they exhibit different pharmacological effects. To investigate the stereoselective pharmacoki-netics, the enantiomeric separation of carvedilol in human plasma was undertaken using capil-lary electrophoresis (CE). Resolution of the enantiomers was achieved using 2-hydoxypropyl-$\beta$-cyclodextrin as the chiral selector. Phosphate buffer (50 mM, pH 4.0) containing 10 mM of 2-hydoxypropropyl-$\beta$-cyclodextrin was used as electrolytic buffer. Achiral separation was carried out with the same electrolytic buffer without chiral selector. Following a single oral administra-tion of 25-mg carvedilol to 11 healthy, male volunteers, stereoselective pharmacokinetic analy-sis was undertaken. The maximum plasma concentrations ( $C_{max}$) were 48.9 and 21.6 ng/mL for (R)-carvedilol and (S)-carvedilol, respectively, determined by the chiral method. The profiles of the plasma concentration of (RS)-carvedilol showed $C_{max}$ of 71.5, 72.2, and 73.5 ng/mL, as determined by the CE, HPLC/FD methods and calculations from the data of the chiral method, respectively.y.y.

Novel upper gastrointestinal bleeding sensor capsule: a first human feasibility and safety trial

  • Lukas Bajer;Marvin Ryou;Christopher C. Thompson;Pavel Drastich
    • Clinical Endoscopy
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    • 제57권2호
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    • pp.203-208
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    • 2024
  • Background/Aims: Upper gastrointestinal bleeding (UGIB) is the most common GI condition requiring hospitalization. The present study aimed to evaluate the safety and feasibility of using the PillSense system (EnteraSense Ltd.), a novel diagnostic tool designed for the rapid in vivo detection of UGIB, in human volunteers. Methods: In the present study, 10 volunteers swallowed a PillSense capsule, followed by 2 servings of an autologous blood preparation. Participants were monitored for capsule passage, overall tolerability of the procedure, and adverse events. Results: The procedure was completed per the protocol established in the present study in 9/10 cases. In 9 of the subjects, after capsule ingestion, the device indicated the absence of blood with sensor output values of 1. After the ingestion of the first blood mixture, the sensor outputs of all devices increased to a range from 2.8 to 4, indicating that each sensor capsule detected blood. The sensor output remained within that range after the ingestion of the second mixture; however, in one case, the baseline capsule signal was positive, because of a preexisting condition. The passage of the capsule was verified in all patients, and no adverse events were reported. Conclusions: The first trial of the PillSense system in human subjects demonstrated the feasibility, safety, and tolerability of utilizing this product as a novel, noninvasive, and easy-to-use triage tool for the diagnosis of patients suspected of having UGIB.

Pharmacokinetic and Pharmacodynamic Characterization of Gliclazide in Healthy Volunteers

  • Kim, Ho-Soon;Yun, Min-Hyuk;Kwon, Kwang-Il
    • Archives of Pharmacal Research
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    • 제26권7호
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    • pp.564-568
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    • 2003
  • Pharmacokinetic and pharmacodynamic properties of gliclazide were studied after an oral administration of gliclazide tablets in healthy volunteers. After an overnight fasting, gliclazide tablet was orally administered to 11 volunteers; Additional 10 volunteers were used as a control group (i.e., no gliclazide administration). Blood samples were collected, and the concentration determined for gliclazide and glucose up to 24 after the administration. Standard pharmacokinetic analysis was carried out for gliclazide. Pharmacodynamic activity of the drug was expressed by increase of glucose concentration ($\Delta$PG), by area under the increase of glucose concentration-time curve ($AUC_{$\Delta$PG}$) or by the difference in increase of glucose concentration ($D_{$\Delta$PG}$) at each time between groups with and without gliclazide administration. Pharmacokinetic analysis revealed that $C_{max}, T_{max}$, CL/F (apparent clearance), V/F (apparent volume of distribution) and half-life of gliclazide were $4.69\pm1.38 mg/L, 3.45\pm1.11 h, 1.26\pm0.35 L/h, 17.78\pm5.27 L, and 9.99\pm2.15 h$, respectively. When compared with the no drug administration group, gliclazide decreased significantly the $AUC_{$\Delta$PG}$ s at 1, 1.5, 2, 2.5, 3 and 4 h (p<0.05). The $\Delta$PGs were positively correlated with $AUC_{gliclazide}$ at 1 and 1.5 h (p<0.05), and the correlation coefficient was maximum at 1 h (r = 0.642) and gradually decreased at 4 h after the administration. The $AUC_{$\Delta$PG}$s were positively correlated with $AUC_{gliclazide}$ at 1, 2, 3 and 4 h (p<0.05), and the maximum correlation coefficient was obtained at 2 h (r=0.642) after the administration. The $D_{$\Delta$PG}$ reached the maximum at 1 h, remained constant from 1 h to 3 h, and decreased afterwards. Therefore, these observations indicated that maximum hypoglycemic effect of gliclazide was reached at approximately at 1.5 h after the administration and the effect decreased, probably because of the homeostasis mechanism, in health volunteers.

12 경맥 전위측정 실험에 대한 연구(2) -정상인과 뇌경색환자의 측정전위 비교- (Differences in Electric Potential of Meridian System (2) -Comparing Electrical Potentials between Healthy Volunteers and Patients with Cerebral Infarction-)

  • 남봉현;최환수
    • Journal of Acupuncture Research
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    • 제17권3호
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    • pp.25-35
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    • 2000
  • Objectives : The characteristic of meridian system has been similar to this of electric potentials in human body. Therefore to measure the electric potentials in healthy volunteers and patients, and to find out the characteristic of meridian system and also to do that of differences between them. Methods : Twenty-nine healthy volunteers, thirty patients diagnosed as a cerebral infarction and wind-syndrome caused by hyperactivity of the liver-yang(肝陽化風) were examined into electric potential of well(井穴) and sea(合穴) points in branches of the twelve meridians by physiograph. Results : Measurements were analyzed by factor analysis, then we obtained that both the right and the left electric potential of well and sea points in branches of the twelves meridians in healthy volunteers were divided into two factors, hand meridian and foot meridian. Where as the left electric potential of those in patients with cerebral infarction were divided into three factors, one is foot meridian, another is hand meridian with the exception of large intestine meridian, and the other is large intestine meridian and also the right electric potential were divided into three factors, foot meridian, hand meridian with the exception of large intestine and lung meridian, and large intestine and lung meridian. Conclusions : In the results, healthy volunteers differ from patients in characteristic of electrical potentials, which means that we are able to catch the characteristic of meridian system by electrical potentials of well and sea points.

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