• Title/Summary/Keyword: healthy volunteers

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The Effect of InGaAlP Laser Transcutaneous Blood Irradiation on Heart Rate Variability in Healthy Adults (InGaAlP 레이저 경피혈액조사가 정상성인의 심박변이도에 미치는 영향)

  • Lee, Tae-Ho;Yeo, Jin-Ju;Seol, Hyun;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.25 no.4
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    • pp.25-33
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    • 2004
  • Objective : The effects of Indium-Gallium-Aluminium-Phosphide(InGaAlP) laser transcutaneous irradiation on heart rate variability(HRV) in healthy adults are investigated with power spectrum analysis(PSA) of HRV. Methods : The control group consisted of 20 healthy volunteers (10 men, 10 women). The experiment was divided into 5 different periods, the pre-1st laser period(10 minutes), the 1st laser period(30 minutes), the post-1st laser period(5 minutes), the 2nd laser period( 30 minutes) and the post-2nd laser period(30 minutes). HRV was measured for 5 minutes at the pre-1 st laser period, the post-l st laser period and the post-2nd laser period. The laser period is the period in which InGaAlP laser transcutaneous Irradiation treatment occurs. Results : 1. SDNN of volunteers at post-1st laser period and post-2nd laser period significantly increased compared with that of the pre- 1 st laser period. 2, Ln(VLF) at post-I st laser period significantly increased compared with that of pre-1st laser period, while Ln(HF) at post-2nd laser period significantly decreased compared with those of pre- I st laser period and post-1st laser period, 3. Ln(TP) at post-1st laser period and post-2nd laser period significantly increased compared with that of pre-1st laser period, 4, LF/HF Ratio at post-2nd laser period significantly increased compared with those of pre-1st laser period and post-1st laser period. But the other variables did not significantly change. Conclusions : The results suggest that InGaAlp laser transcutaneous Irradiation in healthy adults is associated with the autonomic nervous systems. Further study is needed for investigating the effects of laser irradiation on autonomic nervous systems.

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The Effect of Oak Wood Vinegar Extract on Blood Alcohol Concentration and Hangover Syndrome

  • Choi, Young-In;Kwon, Jin-Soo;Song, Yoon-Seok;Wang, Sung-Ho
    • Biomolecules & Therapeutics
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    • v.13 no.1
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    • pp.41-47
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    • 2005
  • The study was conducted to determine whether oak wood vinegar extract influences blood alcohol concentration and hangover syndrome in healthy volunteers. 2% wood vinegar extract was effective to inhibit increase of blood alcohol concentration after alcohol intake and showed significantly different (P<0.1) compared to placebo. By result of questionnaire of volunteers, wood vinegar extract showed effects improving hangover syndrome. In comparative study about blood alcohol concentration and hangover syndrome of wood vinegar extract and other extract that hangover improvement effect was reported, average maximum blood alcohol concentration was lowered in those taking wood vinegar extract than those taking other extract. At drinking completion 210minutes (T210), blood alcohol concentration of those taking wood vinegar extract was the lowest by 0.063% compared with other extract but was not significantly different between in those taking wood vinegar extract and in those taking other extract. However, wood vinegar extract's experimental group was the highest by 0.462 in decrement rate of blood alcohol concentration and, when did P<0.1 by significance level, indicated difference that mean statistically compared to placebo group uniquely. At those taking wood vinegar extract, the improvement rate and the aggravation rate of hangover syndrome was each 87%, 2%. Thus it was concluded that wood vinegar extract showed excellent alcohol oxidation and was effective in hangover improvement.

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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    • v.27 no.9
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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.

The Effect of Mental Stress Stimulation and Acupuncture at Shinmun(HT7) on Heart Rate Variability (정신적 스트레스와 신문(神門)(HT7) 자침(刺鍼)이 정상성인의 심박변이도(HRV)에 미치는 영향)

  • Kang, Mun-Su;Kim, Lak-Hyung
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.1
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    • pp.165-176
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    • 2009
  • Objectives : The purpose of this study was to assess the effects of mental stress stimulation and acupucnture applied at HT7 point on heart rate variability (HRV) in normal subjects. Methods : Thirty seven healthy volunteers participated in this study. The volunteers were randomly allocated into two groups. Both groups performed a mental arithmetic stress test and stroop color-word test for 10 minute. Then, acupuncture needles were inserted on HT7 for the study group and on non-acupucnture point for the control group. HRV was recorded three times at test time and before and after acupuncture stimulation. Results : After giving mental stress stimulation to both groups, LF and LF!HF ratio were increased and HF was decreased significantly. After giving acupuncture to study group, LF and LF/HF ratio were decreased and HF was increased, but it was not significant. After giving acupuncture to control group, LF and LF/HF ratio were increased and HF was decreased, but it was not significant. Conclusions : This results show that mental arithmetic stress test and stroop color-word test contribute to activation of the sympathetic nervous system Acupuncture at HT7 could be relatively useful to decrease sympathetic activity and balance autonomic nervous system for those who are under stress.

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GLP Perspectives of Bioequivalence Studies

  • Jeong, Eun-Ju
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2006.11a
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    • pp.80-86
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    • 2006
  • Bioequivalence is a term in pharmacokinetics used to access the expected in vivo biological equivalence of two proprietary preparations of a drug. Bioequivalence studies are usually performed for generic drugs. Two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilioes after administration in the same molar dose are similar. Bioequivalence is usually accessed by single dose in vivo studies in healthy volunteers and the reference product is usually the innovator product that is marketed. Regulatory definition of bioequivalence is based on the statistical analysis of thebioavailability of the reference and test product. In general, two products are evaluated as bioequivalent if the 90% confidence interval of the relative mean Cmaxand AUC of the test to reference product are within 80.00% to 125.00% in the fasting state. Key process in bioequivalence study is development and validation of bioanalytical method, determination of the drug concentration in the biosamples (usually plasma or serum) obtained from volunteers, calculation of the pharmacokinetic parameters and statistical analysis of the pharmacokinetic parameters. Although current guidelines and regulations do not require the bioequivalence studies to be done under good laboratory practice (CLP), the issues to perform the bioequivalence studies under GLP environment is emerged both from the regulatory and industry side. GLP perspectives of bioequivalence studiesare needed to be discussed in respect to achieve quality assurance in bioequivalence studies.

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Bioequivalence Assesment of Tiropramide in Korean Male Volunteers

  • Park, Young-Jin;Chung, Youn-Bok;Kwon, Oh-Seung
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 2002.07a
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    • pp.205-205
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    • 2002
  • Two formulations of tiropramide {(${\pm}$)${\alpha}$-(benzoylamino)-4-[2-(diethylamino)-ethoxy]-N,N-dipropyl-benzenepropanamide hydrochloride}, an antispasmodic agent, were orally administered to 16 healthy Korean male volunteers by Latin crossover design with the purpose of evaluating bioeqivalence and phamacokinetics of tiropramide. Tiropramide in human plasma was determined by a gas chromatography/nitrogen phosphorus detector. Detection limit of tiropramide was 5 ng/ml. C$\_$max/ values in test and reference formulations were 93.9 ${\pm}$ 54.3 and 96.4 ${\pm}$ 51.6 ng/ml, respectively. AUC$\_$0\longrightarrowlast/ and AUC$\_$0\longrightarrowinf/ were, respectively, 330.7 ${\pm}$ 193.9 and 349.5 ${\pm}$ 205.3 ng.hr/ml for test formulation, 348.9 ${\pm}$ 207.7 and 380.8 ${\pm}$ 239.0 ng.hr/ml for reference formulation. Terminal half-life was 2.3-2.6 hr. Bioavailability differences for C/aub max/ and AUC$\_$0\longrightarrowlast/ were 2.48% and 5.22%, respectively. Minimum detection differences were less than 20% in both C$\_$max/ AUC. Based on this results, two formulations of tiropramide were considered to be bioequivalent

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Study on the Electric Potentials at Biophysical Meridian System (경락 전위를 이용한 경락의 생체물리학적 연구)

  • Choi Hwan-Soo;Nam Bong-Hyun
    • Korean Journal of Acupuncture
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    • v.19 no.2
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    • pp.1-12
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    • 2002
  • Objectives : Assuming That the Characteristic of Meridian System Has Been Similar to This of Electric Potentials in Human Body and That Measurements of Electric Potential at Well and Sea Points in Branches of the Twelve Meridians Will Be Representative of Measurements of the Twelve Meridians, to Measure the Electric Potentials in Healthy Volunteers(HG), Patients Diagnosed As a Cerebral Infarction(CG), a Arrhythmia(AG), a Other Intervertebral Disc Disorder(IG), and a Joint Disorder(JG), and Then to Find Out the Characteristic of Biophysical Meridian System, Finally to Compare with the Results of the Electric Potential in Those Groups. Methods : We Selected Who HG Were Diagnosed by a Blood Test, Urine Examination and Differentiation of Syndromes by Five Viscera among Volunteers, CG by CT and Wind-Syndrome Caused by Hyperactivity of the Liver-Yang, AG by EKG, CT, and Deficiency or the Heart Blood, IG by X-ray or CT and Pain in Waist, and JG by X-ray and Knee Pain. Their Electric Potential of Well and Sea Points in the Meridians Were Measured by hysiograph. Results and Conclusions : Measurements Were Analyzed by Factor Analysis, Analysis of Variance, and Logistic Regression Model, We Obtained That Most of the Results, In Conclusion, Hold Good for the Classical Meridian Doctrine.

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Advanced Method for Determination of Omeprazole in Plasma by HPLC

  • Kang, Won-Ku;Kim, Dong-Sup;Kwon, Dwang-Il
    • Archives of Pharmacal Research
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    • v.22 no.1
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    • pp.86-88
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    • 1999
  • An advance d and sensitive high-performance liquid chromatographic (HPLC) method for determination of omeparzole in human plasma has been developed. After omeprazole was extracted from plasma with diethylether, the organic phase was transferred to another tube and trapped back with 0.1 N NaOH solution. The alkaline aqueous layer was injected into a reversed-phase C8 column. Lansoprazole was used as an internal standard. The mobile phase consisted of 30% of acetonitrile and 70% of 0.2 M $ KH_{2}PO_{4}$, pH 7.0. Recoveries of the analytes and internal standard were >75.48%. The coefficients of variation of intra- and inter-day assay were <5.78 and 4.59% for plasma samples. The detection limit in plasma was 2 ng/ml. The clinical applicability of this assay method was evaluated by determining plasma concentration-time courses of the respective analytes in 24 healthy volunteers after oral administration 40 mg of omeprazole. The present assay is considered to be simple, accurate, economical and suitable for the study of the kinetic disposition of omeprazole in the body.

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Pharmacokinetic Characteristics of Oral Clonazepam in Korean (한국인에서의 경구용 클로나제팜의 약물동력학적 특성)

  • 정지훈;유대식;박준홍;이석용;손의동
    • YAKHAK HOEJI
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    • v.48 no.5
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    • pp.278-284
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    • 2004
  • In order to determine the bioavailability of c1onazepam, an anxiolytic drug, a simple, rapid and sensitive HPLC analysis was developed in healthy Korean volunteers. The analysis system was validated in specificity, accuracy, precision and linearity. The analysis condition we established was 2.58 min and 5 ng/$m\ell$ in retention time and limit of quantitation of c1onazepam, respectively, using reverse-phase C18 column connected to UV detector. Quantitation was performed at 235 nm wave length with p-hydroxybenzoic acid ethyl ester as internal standard. The method involved a simple extraction. In order to study blood level profiles as a function of time, eight volunteers were enrolled and orally took 6 mg clonazepam once. The blood samples were collected from 0 to 120 h after the drug administration. Mean AUC and Cmax value were 1028.17$\pm$568.165 (ng/$m\ell$$.$hr) and 41.25$\pm$10.82 (ng/$m\ell$), respectively. And mean Tmax and T$_{1}$2/ value were 1.08$\pm$0.42 (hr) and 30.78$\pm$3.26 (hr). From the results we determine the pharmacokinetic characteristics of clonazepam in Korean people using a newly developed and useful HPLC method.

Relationship Between Lower Extremity Extensor Strength and Wall Squat Performance

  • Jung, Sung-hoon;Hwang, Ui-jae;Kim, Jun-hee;Jeon, In-cheol;Kwon, Oh-yun
    • Physical Therapy Korea
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    • v.26 no.4
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    • pp.20-28
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    • 2019
  • Background: The wall squat exercise has been recommended for strengthening of the lower extremity muscles with maintaining lumbar lordosis. Although squat has been studied to be related to lower extremity extensor strength, the relationship between wall squat and lower extremity extensor strength unclear. Because squat and wall squat are biomechanically different, study on the relationship is needed. Objects: The purpose of this study was to determine the lower extremity extensor strength associated with wall squat performance. Methods: 74 healthy volunteers were recruited to participate in this study. The volunteers were measured hip and knee extensors strength and then performed wall squat exercise for maximum count. Results: We found significant relationships between wall squat performance and hip extensor strength normalized by body weight, knee extensor strength normalized by body weight and the composite value. In a regression analysis, hip extensor strength normalized by body weight explained 29% of the variation in wall squat performance in males and 35% in females. Conclusion: These results demonstrate that hip extensor strength normalized by body weight is critical to wall squat performance in both sexes.