• Title/Summary/Keyword: Healthy volunteers

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Feasibility of Free-Breathing, Non-ECG-Gated, Black-Blood Cine Magnetic Resonance Images With Multitasking in Measuring Left Ventricular Function Indices

  • Pengfei Peng;Xun Yue;Lu Tang;Xi Wu;Qiao Deng;Tao Wu;Lei Cai;Qi Liu;Jian Xu;Xiaoqi Huang;Yucheng Chen;Kaiyue Diao;Jiayu Sun
    • Korean Journal of Radiology
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    • v.24 no.12
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    • pp.1221-1231
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    • 2023
  • Objective: To clinically validate the feasibility and accuracy of cine images acquired through the multitasking method, with no electrocardiogram gating and free-breathing, in measuring left ventricular (LV) function indices by comparing them with those acquired through the balanced steady-state free precession (bSSFP) method, with multiple breath-holds and electrocardiogram gating. Materials and Methods: Forty-three healthy volunteers (female:male, 30:13; mean age, 23.1 ± 2.3 years) and 36 patients requiring an assessment of LV function for various clinical indications (female:male, 22:14; 57.8 ± 11.3 years) were enrolled in this prospective study. Each participant underwent cardiac magnetic resonance imaging (MRI) using the multiple breath-hold bSSFP method and free-breathing multitasking method. LV function parameters were measured for both MRI methods. Image quality was assessed through subjective image quality scores (1 to 5) and calculation of the contrast-to-noise ratio (CNR) between the myocardium and blood pool. Differences between the two MRI methods were analyzed using the Bland-Altman plot, paired t-test, or Wilcoxon signed-rank test, as appropriate. Results: LV ejection fraction (LVEF) was not significantly different between the two MRI methods (P = 0.222 in healthy volunteers and P = 0.343 in patients). LV end-diastolic mass was slightly overestimated with multitasking in both healthy volunteers (multitasking vs. bSSFP, 60.5 ± 10.7 g vs. 58.0 ± 10.4 g, respectively; P < 0.001) and patients (69.4 ± 18.1 g vs. 66.8 ± 18.0 g, respectively; P = 0.003). Acceptable and comparable image quality was achieved for both MRI methods (multitasking vs. bSSFP, 4.5 ± 0.7 vs. 4.6 ± 0.6, respectively; P = 0.203). The CNR between the myocardium and blood pool showed no significant differences between the two MRI methods (18.89 ± 6.65 vs. 18.19 ± 5.83, respectively; P = 0.480). Conclusion: Multitasking-derived cine images obtained without electrocardiogram gating and breath-holding achieved similar image quality and accurate quantification of LVEF in healthy volunteers and patients.

Bioequivalence of Cefamandole Nafate I.V. (Mandol and Mancef) of Human Volunteers (Cefamandole nafate 함유 주사제의 지원자에 대한 생물학적 동등성 시험)

  • Kwon, Kwang-Il;Lee, Hye-Suk;Zee, Ok-Pyo
    • YAKHAK HOEJI
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    • v.34 no.5
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    • pp.334-340
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    • 1990
  • The bioequivalence of Mandol and Mancef (cefamondole nafate injection preparation) was investigated for 8 healthy human volunteers. Cefamandole nafate hydrolysis to cefamandole base in the blood and shows antibacterial activity. As the rate of the hydrolysis can be varied according to the buffer used in the preparation, the bioequivalence of cefamandole nafate I.V. was studied. A new HPLC method, the column switching technique, was developed and used for the simultaneous determination of cefamandole and cefamandole nafate in the plasma and in the urine. There were no statistically significant difference in between Mandol and Mancef for the parameters of AUC and Cp 0.25 hr even through the power of the test was not enough.

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Influence of Oxygen to Population Pharmacokinetics/Pharmacodynamics of Alcohol in Healthy Volunteers (건강한 성인에서의 알코올의 집단 약물동태/약물동력에 미치는 산소의 영향 연구)

  • Song, Byungjeong;Back, Hyun-moon;Hwang, Si-young;Chae, Jung-woo;Yun, Hwi-yeol;Kwon, Kwang-il
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.4
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    • pp.258-266
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    • 2017
  • Objective: To develop a population pharmacokinetics (PK)/pharmacodynamics (PD) model for alcohol in healthy volunteers and to elucidate individual characteristics to affects alcohol's PK or PD including dissolved oxygen. Methods: Following multiple intakes of total 540 mL alcohol (19.42 v/v%) to healthy volunteer, blood alcohol concentration was measured using a Breathe alcohol analyser (Lion SD-400 $Alcolmeter^{(R)}$). A sequential population PK/PD modeling was performed using NONMEM (ver 7.3). Results: Eighteen healthy volunteer were included in the study. PK model of alcohol was well explained by one-compartment model with first-order absorption and Michaelis-Menten elimination kinetics. $K_a$, V/F, $V_{max}$, $K_m$ is $8.1hr^{-1}$, 73.7 L, 9.65 g/hr, 0.041 g/L, respectively. Covariate analysis revealed that gender significantly influenced $V_{max}$ (Male vs Female, 9.65 g/hr vs 7.38 g/hr). PD model of temporary systolic blood pressure decreasing effect of alcohol was explained by biophase model with inhibitory $E_{max}$ model. $K_{e0}$, $I_{max}$, $E_0$, $IC_{50}$ were $0.23hr^{-1}$, 44.9 mmHg, 138 mmHg, 0.693 g/L, respectively. Conclusion: Model evaluation results suggested that this PK/PD model was robust and has good precision.

Population Pharmacokinetic Characteristics of Levosulpiride and Terbinafine in Healthy Male Korean Volunteers

  • Lee, Yong-Bok
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.84-87
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    • 2003
  • The purposes of this study were to evaluate the population pharmacokinetics of levosulpiride and terbinafine according to several pharmacokinetic models and to investigate the influence of characteristics of subjects such as age, body weight, height and serum creatinine concentration on the pharmacokinetic parameters of levosulpiride and terbinafine, respectively. (omitted)

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The Effects of Incense Smokes of 'Cheung-Woon' on HRV ('淸雲(청운)'의 훈법(熏法)이 심박변이도(HRV)에 미치는 영향)

  • Uhm, Ji-Tae;Kim, Kyoung-Shin;Kim, Byoung-Soo
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.3
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    • pp.89-98
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    • 2012
  • Objectives : This study aims to assess the effects of incense smokes of 'Cheung-Woon'(consists of several kind of herbal powder) on autonomic nervous system activity and attention in healthy individuals. Methods : A total of 48 healthy volunteers participated in this study. The volunteers were examined with heart rate variability (HRV) before and after incense smokes inhalation of 'Cheung-Woon'. HRV measured the mean RR, mean HR, SDNN, VLF, LF, HF, TP, norm LF, norm HF, and LF/HF ratio. 'Cheung-Woon' consists of 7 herbal powders, known for useful effect on attention. Results : After inhalation smokes of 'Cheung-Woon', the mean RR, and mean HR were decreased and SDNN, VLF, LF, TP were increased, but it's not significant. Further, HF, and norm HF were decreased, and LF/HF ratio, and norm LF was increased significantly (p<0.01). Conclusions : This results (Ed note: 'this result' or 'these results') show that incense smokes inhalation of 'Cheung-Woon' is an effective way of decreasing parasympathetic nervous activity and increasing sympathetic activity and attention.