• Title/Summary/Keyword: Healthy Volunteers

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What Is Normal for an Aging Heart?: A Prospective CMR Cohort Study

  • Johannes Kersten;Carsten Hackenbroch;Muriel Bouly;Benoit Tyl;Peter Bernhardt
    • Journal of Cardiovascular Imaging
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    • v.30 no.3
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    • pp.202-211
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    • 2022
  • BACKGROUND: This study aims to investigate normal changes throughout aging of the heart in cardiac magnetic resonance (CMR) imaging in healthy volunteers. While type 2 diabetes mellitus is a frequent finding in the elderly population, also the influence of this circumstance in otherwise healthy persons is part of our study. METHODS: In this prospective single-center trial, 75 healthy subjects in distinct age groups and 10 otherwise healthy diabetics were enrolled. All subjects underwent functional, flow sensitive, native T2- and T1-mapping in a 1.5T CMR scanner. RESULTS: No differences in right and left ventricular ejection fractions were observed between aging healthy groups. Bi-ventricular volumes lowered significantly (p<0.001) between the age groups. There was also a significant decrease in myocardial T1 values, aortic distensibility, and left ventricular peak diastolic strain rates. There were no differences in T2 mapping and the other deformation parameters. Patients with type 2 diabetes mellitus had lower end-diastolic volume indexes; all the other measurements were comparable. CONCLUSIONS: Aging processes in the healthy heart involve a decrease in ventricular volumes, with ejection fractions remaining normal. Stiffening of the myocardium and aorta and a decrease in T1 values are potential indications of age-related remodeling. Type 2 diabetes mellitus seems to have no major influence on aging processes of the heart.

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.

Bioequivalence Assessment of Domperidone Maleate Tablets in Healthy Korean Volunteers

  • Kim, Sung-Chull;Lee, Jun-Woo;Yoo, An-Na;Chang, Hyun-Sung;Lee, Kyung-Hee;Park, Jong-Min;Nam, Doo-Hyun
    • Biomolecules & Therapeutics
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    • v.11 no.2
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    • pp.145-150
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    • 2003
  • The bioequivalence of two tablet formulations of 12.72mg domperidone maleate (Sinil "$Perinal^{\circledR}$" tablets vs. Janssen Korea "Motilium-$M^{\circledR}$" tablets) was assessed in healthy Korean volunteers after oral administration in a randomized crossover study. Blood samples were collected at spccified time intervals, and plasma concentration was measured as the amount of domperidone base using a validated HPLC method. The pharmacokinetic parameters of $AUC_{0{\rightarrow}48},\; C_{max},\;T_{max}$ and $t_{1/2}$ were determined from plasma concentration-time profile of two formulations. Any significant statistical differences were not observed between these two formulations. On the evaluation of bioequivalence according to Korea Food and Drug Administration Guideline, 90% confidence limits after logmithmic transformation fell within the acceptable range (log 0.8∼log 1.25). Based on these data, it can be concluded that two domperidone maleate tablets showed comparable pharmacokinetic profiles, which means that the Sinil "$Perinal^{\circledR}$" tablet is bioequivalent to the Janssen Korea ""Motilium-M$^{\circledR}$".

The Spermatogenic Effect of 50% Ethanol Extracts of Yacon in Healthy Male Volunteers (야콘 50% 에탄올 추출물의 성인 남성의 정자 수 증가효과)

  • Park, Jeong-Sook;Hwang, Seock-Yeon;Han, Kun
    • YAKHAK HOEJI
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    • v.53 no.5
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    • pp.250-258
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    • 2009
  • Male reproductive function seems to have deteriorated considerably in the past 4 to 5 decades. It was observed a significant decline in mean sperm counts from $113{\times}10^6/ml$ in 1940 to $66{\times}10^6/ml$ in 1990; a fall of $0.94{\times}10^6/ml/year$. We reported that Yacon tuber extracts have spermatogenic effects in rat. In the present study, we tested the spermatogenic effect of Yacon tuber extracts in healthy male volunteers. Subjects were assigned randomly to the control group and the Yacon ethanol extracts administered group (each 12 subjects). And, placebo or Yacon tuber extracts (100 ml) were administered two times daily, by oral for 3 months. Sperm numbers, biochemical parameters and hormone levels were recorded before starting administration, then every month. The Yacon tuber extracts administered group showed significant time dependant increases in according to administration period. Especially, the numbers of sperm increased by 54% after 3 months of administration. And, in Yacon tuber extracts administered group, testosterone and estradiol level were significantly higher than placebo group. On the other hands, Yacon tuber extracts didn't show any toxicity in glucose and lipid metabolism and liver and kidney function. The results of the present study suggest that Yacon tuber extract is a possible therapeutic for the treatment of sperm deficiency.

Pharmacodynamic evaluation of hypoglycemic effect of Damtab in healthy adult male volunteers

  • Sahu, Pratap Kumar;Pillai, KK;Saha, Nilanjan;Sharma, Manju;Najmi, AK
    • Advances in Traditional Medicine
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    • v.7 no.2
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    • pp.205-210
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    • 2007
  • The objectives of the study were (1) To evaluate the safety and tolerability of Damtab. (2) To characterize hypoglycemic effect of Damtab, if any. (3) To evaluate insulin sensitivity effect of Damtab, if any. Hypoglycemic effect of Damtab (700 mg and 1,400 mg) were examined. Gliclazide (80 mg) was used as an active control. Placebo was used as control. Breakfast was given, half an hour before dosing whereas lunch, snacks and dinner were given at 6, 10 and 14 h post dose. An oral glucose tolerance test was conducted to calculate the insulin sensitivity index from the values of glucose and insulin during oral glucose tolerance test. Both giclazide 80 mg and Damtab 1,400 mg significantly lowered plasma glucose level up to 6 h. Insulin sensitivity index of Damtab (1,400 mg) was found to be similar to that of placebo. A significant increase in insulin level at 1 h post dose of Damtab (1,400 mg) was observed. Damtab 700 mg shows placebo like effect whereas Damtab 1,400 mg possesses hypoglycemic effect.

Bioequivalence Assessment of Triamcinolone Tablets in Healthy Male Human Volunteers

  • Pyo, Hee-Soo;Jang, Moon-Sun;Chung, Youn-Bok;Kwon, Oh-Seung
    • Biomolecules & Therapeutics
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    • v.10 no.3
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    • pp.180-185
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    • 2002
  • The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang Triamcinolone$\textregistered$ vs. Wyeth Korea Ledercoat$\textregistered$) was assessed in healthy male volunteers after oral administration of 16mg triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0\longrightarrowlast}$, $AUC_{0\longrightarrowinf}$ and $T_{1/2, \beta} were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to Korea Food and Drug Administration Guideline. The analysis of variance did not show any significant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang triamcinlone$\textregistered$ tablet is bioequivalent to the Wyeth Korea Ledercoat$\textregistered$ tablet.

Bioequivalence Assessment of Two Brands (Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ vs. Wyeth Korea $\textrm{Ledercoat}^{(R)}$ 4 mg Tablets) of Triamcinolone in Healthy Male Human Volunteers

  • Kwon, Oh-Seung;Heesoo Pyoa;Jang, Moon-Sun;Chung, Youn-Bok
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 2002.07a
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    • pp.206-206
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    • 2002
  • The bioequivalence of two 4 mg triamcinolone tablets (Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ vs. Wyeth Korea $\textrm{Ledercoat}^{(R)}$) was assesed in healthy male Korean volunteers after oral administration of 16 mh triamcinolone in a randomized crossover study. Blood samples were collected at specified time intervals, and plasma was analyzed for triamcinolone using a validated HPLC method. The pharmacokinetic parameters of $T_{max}$, $C_{max}$, $AUC_{0{\longrightarrow}last}$. $AUC_{0{\longrightarrow}imf}$, and $T_{1/2,\beta}$ were determined from plasma concentration-time profile of two formulations. The pharmacokinetic parameters were statistically compared to evaluate bioequivalence between two formulations, according to the United State or Korea Food and Drug Administration Guidelines. The analysis of variance did not show any signigicant difference between the two formulations and 90% confidence limits fell within the acceptable range (80-120%) for bioequivalence. Based on these data it was concluded that the two products showed comparable pharmacokinetic profiles and that the Dong-Kwang $\textrm{Tramcinolone}^{(R)}$ tablet is bioequivalent to the $\textrm{Ledercoat}^{(R)}$ tablet produced by Wyeth Korea.

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