• Korean Journal of Clinical Pharmacy
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• v.21 no.3
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• pp.224-227
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• 2011

Entecavir is a potent and selective guanosine analogue that has demonstrated a significant antiviral efficacy against hepatitis B virus (HBV). The aim of this study was to evaluate the safety and pharmacokinetic profile after a single dose of entecavir 1 mg administration in Korean healthy male subjects. Eight volunteers were enrolled. After a single dose of 1 mg entecavir was orally administered, blood samples were collected at specific time intervals from 0-168 hours. The plasma concentrations of entecavir were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles. The mean values for $AUC_{last}$ and $AUC_{inf}$ were $14.84{\pm}7.81ng{\cdot}hr/mL$ and $20.71{\pm}8.80ng{\cdot}hr/mL$, respectively. The mean value for $C_{max}$ was $9.19{\pm}4.91ng/ml$ and median value for $t_{max}$ was 0.58 hr. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. The results are suggested to be useful in clinical trials of entecavir in Korean subject including bioequivalence study.

• Journal of Ginseng Research
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• v.40 no.4
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• pp.375-381
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• 2016

Background: We evaluated the drug interaction profile of Red Ginseng (RG) with respect to the activities of major cytochrome P450 (CYP) enzymes and the drug transporter P-glycoprotein (P-gp) in healthy Korean volunteers. Methods: This article describes an open-label, crossover study. CYP probe cocktail drugs, caffeine, losartan, dextromethorphan, omeprazole, midazolam, and fexofenadine were administered before and after RG supplementation for 2 wk. Plasma samples were collected, and tolerability was assessed. Pharmacokinetic parameters were calculated, and 90% confidence intervals (CIs) of the geometric mean ratios of the parameters were determined from logarithmically transformed data using analysis of variance after RG administration versus before RG administration. Results: Fourteen healthy male participants were evaluated, none of whom were genetically defined as poor CYP2C9, 2C19, and CYP2D6 metabolizers based on genotyping. Before and after RG administration, the geometric least-square mean metabolic ratio (90% CI) was 0.870 (0.805-0.940) for caffeine to paraxanthine (CYP1A2), 0.871 (0.800-0.947) for losartan (CYP2C9) to EXP3174, 1.027 (0.938-1.123) for omeprazole (CYP2C19) to 5-hydroxyomeprazole, 1.373 (0.864-2.180) for dextromethorphan to dextrorphan (CYP2D6), and 0.824 (0.658-1.032) for midazolam (CYP3A4) to 1-hydroxymidazolam. The geometric mean ratio of the area under the curve of the last sampling time ($AUC_{last}$) for fexofenadine (P-gp) was 0.963 (0.845-1.098). Administration of concentrated RG for 2 wk weakly inhibited CYP2C9 and CYP3A4 and weakly induced CYP2D6. However, no clinically significant drug interactions were observed between RG and CYP and P-gp probe substrates. Conclusion: RG has no relevant potential to cause CYP enzyme- or P-gp-related interactions.

• Journal of Biomedical Engineering Research
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• v.30 no.5
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• pp.381-392
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• 2009

Due to the aging effect, older people have relatively weaker muscular performance, less range of motion in the joint articulation, and the lower sense of equilibrium than younger people. These factors attribute to their slow and clumsy ingress/egress motion. In order to analyze ingress/egress motion strategy of the elderly, healthy thirty 65 or more years old volunteers were recruited. The health condition of the each volunteer was verified by the medical checkup and also their physical capabilities were quantified by six fitness tests. Through the video analysis, older driver's ingress/egress motion strategies were classified and statistically investigated. For a comparison purpose, another thirty young volunteers also participated in the same test protocol and their ingress/egress motion strategies were also included in the statistical analysis.

• 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.

• 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.

• 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).

• 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.

• 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.

• 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.

• 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.