• Title/Summary/Keyword: Healthy volunteers

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Effects of Kimchi Consumption on Iron Status in Adult Male Volunteers (김치의 섭취가 성인 남성의 철분영양상태 지표에 미치는 영향)

  • 오영주
    • Journal of Nutrition and Health
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    • v.30 no.10
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    • pp.1188-1194
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    • 1997
  • The aim of this was to investigate whether the regular consumption of kimchi influences the iron status (RBC , Hb, Ht, MCH, MCV, MCHC, transferrin , serum iron, and ferritin) in volunteers. Healthy male adults(n=12) took part in the study subdivided into the control Ⅰ-phase(for 2weeks), kimchi-phase (for 4 weeks), and control Ⅱ-phase(for 2 weeks). In addition to their normal diet, participant consumed 300g of lactic acid fermented Chinese cabbage kimchi daily for four weeks. In the control Ⅰ and control Ⅱ phases, the participants kept up their normal diets without consuming any fermented foods. Dietary intakes were recorded for 3 consecutive days in each phase, with the aid of household measures. Every two weeks. blood specimens were analysed. Significant differences(p<0.05) between the phases were found in MCHC, and transferrin in blood were not significantly changed during kimchi consumption. However, serum iron and ferritin levels were significantly increased(p<0.05) during kimchi consumption, achieving the highest levels in the fourth week of the kimchi components(ascrobic acid, sulfer compound, organic acid, capsaicin, gingerol , allicin). Because of lacticacid fermented kimchi's potential to prevent anemia , the consumption of this food can be recommended.

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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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Metabolism of Ginseng Saponins and Its Significance

  • Yamasakia Kazuo;Kasai Ryoji;Matsuura Hiromichi;Tanaka Osamu
    • Proceedings of the Ginseng society Conference
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    • 2002.10a
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    • pp.253-261
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    • 2002
  • To follow the metabolic fate of aglycone of ginseng saponins,in vitro and in vivo experiments were performed. Incubation of 20(S)-prtopanaxatriol (1) with rat liver S9 fraction afforded unique ocotillol derivatives, 20, 24-epoxysides (3 and 4). Also 20(S)-prtopanaxadiol (2) gave the corresponding epoxides (5). Healthy volunteers were taken with Sanchi Ginseng, which contains protopanaxatriol and protopanaxadiol saponins and no ocotillol saponins. From the alkaline hydrolysate of the urine samples of these volunteers,3 was detected as well as 1, and the ratio of 3/1 increased up to 2.0 at the maximum at 50 hrs. Biochemical significance of the ocotillol derivatives is discussed, since the main bioactive saponin in Panax vietnamensis is an ocotillol-type saponin, majonoside R2 (7).

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Phase I Clinical Trial of Prostate-Specific Membrane Antigen-Targeting 68Ga-NGUL PET/CT in Healthy Volunteers and Patients with Prostate Cancer

  • Minseok Suh;Hyun Gee Ryoo;Keon Wook Kang;Jae Min Jeong;Chang Wook Jeong;Cheol Kwak;Gi Jeong Cheon
    • Korean Journal of Radiology
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    • v.23 no.9
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    • pp.911-920
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    • 2022
  • Objective: 68Ga-NGUL is a novel prostate-specific membrane antigen (PSMA)-targeting tracer based on Glu-Urea-Lys derivatives conjugated to a 1,4,7-triazacyclononane-N,N',N''-triacetic acid (NOTA) chelator via a thiourea-type short linker. This phase I clinical trial of 68Ga-NGUL was conducted to evaluate the safety and radiation dosimetry of 68Ga-NGUL in healthy volunteers and the lesion detection rate of 68Ga-NGUL in patients with prostate cancer. Materials and Methods: We designed a prospective, open-label, single-arm clinical trial with two cohorts comprising six healthy adult men and six patients with metastatic prostate cancer. Safety and blood test-based toxicities were monitored throughout the study. PET/CT scans were acquired at multiple time points after administering 68Ga-NGUL (2 MBq/kg; 96-165 MBq). In healthy adults, absorbed organ doses and effective doses were calculated using the OLINDA/EXM software. In patients with prostate cancer, the rates of detecting suspicious lesions by 68Ga-NGUL PET/CT and conventional imaging (CT and bone scintigraphy) during the screening period, within one month after recruitment, were compared. Results: All 12 participants (six healthy adults aged 31-32 years and six prostate cancer patients aged 57-81 years) completed the clinical trial. No drug-related adverse events were observed. In the healthy adult group, 68Ga-NGUL was rapidly distributed, with the highest uptake in the kidneys. The median effective dose coefficient was calculated as 0.025 mSv/MBq, and cumulative activity in the bladder had the highest contribution. In patients with metastatic prostate cancer, 229 suspicious lesions were detected using either 68Ga-NGUL PET/CT or conventional imaging. Among them, 68Ga-NGUL PET/CT detected 199 (86.9%) lesions and CT or bone scintigraphy detected 114 (49.8%) lesions. Conclusion: 68Ga-NGUL can be safely applied clinically and has shown a higher detection rate for the localization of metastatic lesions in prostate cancer than conventional imaging. Therefore, 68Ga-NGUL is a valuable option for prostate cancer imaging.

Sa-Am Acupuncture with Spleen Seung-gyuck induces an acute increase of radial pulse parameters related to arterial stiffness in healthy subjects: A comparative study of Jung-gyuck and Seung-gyuck

  • Yim, Yun-Kyoung
    • The Journal of Korean Medicine
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    • v.35 no.2
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    • pp.19-27
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    • 2014
  • Objectives: To investigate the different effects of Sa-Am acupuncture with Spleen Jung-gyuck and Spleen Seung-gyuck on the radial pulse in healthy subjects. Methods: Sixty healthy volunteers (30 males and 30 females) participated in this study. The participants were randomly divided into three groups: control (C), Sa-Am acupuncture with Spleen Jung-gyuck (SP+) and Sa-Am acupuncture with Spleen Seung-gyuck (SP-). The radial pulse was measured using a multi-step tonometry system before, and 0, 30 and 60 minutes after acupuncture. Results: The heart rate adjusted radial augmentation index (RAI/HR) and high-tensioned pulse area (W area) significantly increased in the SP- group compared to the C and SP+ groups in males. The systolic pulse period (T4) increased significantly in the SP- group compared to the C and SP+ groups in females. The RAI/HR had positive correlations with W area and T4. Conclusion: The effects of Sa-Am acupuncture with Spleen Jung-gyuck and Spleen Seung-gyuck are different. Sa-Am acupuncture with Spleen Seung-gyuck induces acute increases of radial pulse parameters related to arterial stiffness in healthy subjects.

Vascular dysfunction in patients with type 2 diabetes mellitus

  • Ekta, Khandelwal;Mahaveer Jain;Sumeet Tripathi
    • Annals of Clinical Neurophysiology
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    • v.25 no.1
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    • pp.32-37
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    • 2023
  • Background: Type 2 diabetic mellitus (T2DM) is an emerging global pandemic which is associated with lots of co-morbidities and reported vascular dysfunctions. T2DM associated vascular dysfunctions leads to vasculopathy in the form of altered peripheral vascular dynamics. Cold stress test (CST) is a reliable sympathetic reactivity test used for assessing vascular dysfunctions. In this study we are trying to quantify vascular dysfunctions in T2DM patients non invasively by various parameters of photoplethysmography (PPG) of cold stress test. Methods: Case control study had done in referral health center AIIMS, Raipur. Parameters are recorded by finger-PPG before, during and after CST (1 min) in 2 groups, control (n = 20 healthy volunteers) and case (n = 20 diagnosed T2DM patients). Results: Due to cold stress, PPG parameter peak amplitude was significantly decreased in both healthy and T2DM groups (p <0.001 and p <0.001, respectively). However, recovery trend of amplitude was significantly slow in T2DM compared to healthy subjects. Another PPG parameter peak to peak interval was significantly higher in healthy group compared to T2DM patients. Conclusions: This study showed that T2DM patients has significant deranged pulse volume parameters like amplitude and peak to peak interval can be used to objectively quantify the vasculopathy in T2DM patients by using sympathetic reactivity to cold stress.

Effects of gut microbiota on the pharmacokinetics of protopanaxadiol ginsenosides Rd, Rg3, F2, and compound K in healthy volunteers treated orally with red ginseng

  • Kim, Jeon-Kyung;Choi, Min Sun;Jeung, Woonhee;Ra, Jehyeon;Yoo, Hye Hyun;Kim, Dong-Hyun
    • Journal of Ginseng Research
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    • v.44 no.4
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    • pp.611-618
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    • 2020
  • Background: It is well recognized that gut microbiota is involved in the biotransformation of ginsenosides by converting the polar ginsenosides to nonpolar bioactive ginsenosides. However, the roles of the gut microbiota on the pharmacokinetics of ginsenosides in humans have not yet been fully elucidated. Methods: Red ginseng (RG) or fermented red ginseng was orally administered to 34 healthy Korean volunteers, and the serum concentrations of the ginsenosides were determined using liquid chromatography-tandem mass spectrometry. In addition, the fecal ginsenoside Rd- and compound K (CK)eforming activities were measured. Then, the correlations between the pharmacokinetic profiles of the ginsenosides and the fecal ginsenoside-metabolizing activities were investigated. Results: For the RG group, the area under the serum concentratione-time curve values of ginsenosides Rd, F2, Rg3, and CK were 8.20 ± 11.95 ng·h/mL, 4.54 ± 3.70 ng·h/mL, 36.40 ± 19.68 ng·h/mL, and 40.30 ± 29.83 ng·h/mL, respectively. For the fermented red ginseng group, the the area under curve from zero to infinity (AUC) values of ginsenosides Rd, F2, Rg3, and CK were 187.90 ± 95.87 ng·h/mL, 30.24 ± 41.87 ng·h/mL, 28.68 ± 14.27 ng·h/mL, and 137.01 ± 96.16 ng·h/mL, respectively. The fecal CK-forming activities of the healthy volunteers were generally proportional to their ginsenoside Rd-eforming activities. The area under the serum concentration-time curve value of CK exhibited an obvious positive correlation (r = 0.566, p < 0.01) with the fecal CK-forming activity. Conclusion: The gut microbiota may play an important role in the bioavailability of the nonpolar RG ginsenosides by affecting the biotransformation of the ginsenosides.

Pharmacokinetic and Bioequivalence Study of Zolpidem Tartate in Healthy Volunteers

  • Park, Jun-Sung;Myung, Ja-Hye;Wang, Hun-Sik;Koo, Ja-Seong;Cho, Won-Kyung;Cha, Kwang-Ho;Park, Hee-Jun;Kim, Min-So;Kim, Jeong-Soo;Hwang, Sung-Joo
    • Journal of Pharmaceutical Investigation
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    • v.41 no.3
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    • pp.191-196
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    • 2011
  • In this study simple and sensitive high performance liquid chromatographic method using a commercially available column, was developed and validated for the determination of zolpidem tartrate in human plasma. The developed method with suitable validation was applied to a bioequivalence study of two different kinds of zolpidem tartrate. Two different formulations containing 10 mg of zolpidem tartate (CAS : 99294-93-6) were compared in 24 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, cross-over design in 24 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 12 h. The mean $AUC_{0-12h}$, $C_{max}$, $T_{max}$ and $T_{1/2}$ were $676.6{\pm}223.4$ $ng{\cdot}h{\cdot}mL^{-1}$, $177.4{\pm}34.2$ $ng{\cdot}mL^{-1}$, and $0.8{\pm}0.4$ and $3.5{\pm}2.1$, respectively, for the test formulations, and $640.7{\pm}186.6$ $ng{\cdot}h{\cdot}mL^{-1}$, $193.0{\pm}64.5$ $ng{\cdot}mL^{-1}$, and $0.9{\pm}0.4$ and $2.7{\pm}0.9$, respectively, for the reference formulation. Both primary target parameters $AUC_{0-12h}$ and $C_{max}$ were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of $AUC_{0-12h}$ and $C_{max}$ were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of zolpidem tartate are considered to be bioequivalent.

Quantitative analysis of the effect of fraction of inspired oxygen on peripheral oxygen saturation in healthy volunteers

  • Kang, Bong Jin;Kim, Myojung;Bang, Ji-Yeon;Lee, Eun-Kyung;Choi, Byung-Moon;Noh, Gyu-Jeong
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.20 no.2
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    • pp.73-81
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    • 2020
  • Background: The international organization for standardization (ISO) 80601-2-61 dictates that the accuracy of a pulse oximeter should be assessed by a controlled desaturation study. We aimed to characterize the relationship between the fraction of inspired oxygen (FiO2) and peripheral oxygen saturation (SpO2) using a turnover model by retrospectively analyzing the data obtained from previous controlled desaturation studies. Materials and Methods: Each volunteer was placed in a semi-Fowler's position and connected to a breathing circuit to administer the hypoxic gas mixture containing medical air, oxygen, nitrogen, and carbon dioxide. Volunteers were exposed to various levels of induced hypoxia over 70-100% arterial oxygen saturation (SaO2). The study period consisted of two rounds of hypoxia and the volunteers were maintained in room air between each round. FiO2 and SpO2 were recorded continuously during the study period. A population pharmacodynamic analysis was performed with the NONMEM VII level 4 (ICON Development Solutions, Ellicott City, MD, USA). Results: In total, 2899 SpO2 data points obtained from 20 volunteers were used to determine the pharmacodynamic characteristics. The pharmacodynamic parameters were as follows: kout = 0.942 1/min, Imax = 0.802, IC50 = 85.3%, γ = 27.3. Conclusion: The changes in SpO2 due to decreases in FiO2 well explained by the turnover model with inhibitory function as a sigmoidal model.

Effectiveness of Cold Stress Thermography in the Diagnosis of Complex Regional Pain Syndrome Type 1 (복합부위통증증후군 1형 환자에서 한냉부하 적외선체열촬영의 유용성 평가)

  • Park, Eun Jung;Han, Kyung Ream;Chae, Yun Jeong;Jeong, Won Ho;Kim, Chan
    • The Korean Journal of Pain
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    • v.19 no.2
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    • pp.159-163
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    • 2006
  • Background: Despite the enormous amount of basic research on neuropathic pain, there is the lack of an objective diagnostic test for complex regional pain syndrome (CRPS). The aim of this study was to evaluate the usefulness of cold stress thermography in the diagnosis of CRPS. Methods: The study involved 12 patients with CRPS type 1, according to the IASP criteria, who were compared with 15 normal healthy volunteers. All subjects underwent thermographic examination under baseline conditions at $21^{\circ}C$. A cold stress test (CST; $10^{\circ}C$ water for 1 minute) was then applied to both hands below the wrists, immediate, and after 10 and 20 minutes. Results: The temperature asymmetry between the patients with CRPS and the volunteers showed significant discrimination at the baseline and after a 20 minute recovery period from the CST. Among the study subjects having temperature asymmetry of both hands of less than $1^{\circ}C$ (8 out of 12 CRPS patients and 14 out of 15 volunteer), 7 (87.5%) of the 8 CRPS patients and 3 (21%) of the 14 volunteers showed a temperature difference of more than $1^{\circ}C$ after the 20 minute recovery period. The actual temperature values during the four periods did not discriminate between the patients with CRPS and the volunteers. Conclusions: Thermography, under the CST, could be a more objective test for the diagnosis of CRPS. A temperature asymmetry greater than $1^{\circ}C$ during the 20 minute recovery period following CST provides strong diagnostic information about CRPS, with both high sensitivity and specificity.