• 대한임상약리학회:학술대회논문집
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• 2007.11a
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• pp.87-87
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• 2007

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• Proceedings of the PSK Conference
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• 2001.10a
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• pp.316.3-317
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• 2001

• 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.

• 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$^{\circledR}$".

• 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.

• 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.

• 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.

• 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.

• Archives of Pharmacal Research
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• v.17 no.2
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• pp.80-86
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• 1994

The bioavailability of digoxin generic tablets manufactures in Korea (formulations A & B) wwere compared to a standard (formulation C; Lanoxin brand digoxin, Burroughs Wellcome, USA) in 12 healthy Korean male volunteers (mean age 31.4 years) in a single dose, randomized, complete block crossover study. Using a latin square design, each of the subjects was randomized to the order number and allocated to each of the three treatments of 0.5mg oral digoxin. Digoxin conc4ntrations in serum and urine samples collected for 48 hours after dosing were measured by fluoprescence polarization immunoassy and radioimmunoassy, respectively. Treatments were compared by using nonlinear least squares regession analysis to evaluate the following pharmacokinetic parameters : maximum serum concentation $(C_{max})$; time of maximum serum concentation $(T_{max})$; area under the serum concentration-time curve $AUC_{0-12}$, $C_{max}$\;and\;(AUC_{0-12})$; and cummulative urinary excretion for 0-48 hours $(CLE_{0-48}.\;Mean\;AUC_{0-12},\;C_{max},\;and\;CUE_{0-48}$ values for formulations B and C were significantly different from formulation A (P<0.001), but not significantly diffeerent form each other. Basede on $AUL_{0-12}\;and\;CUE_{0-48}$ respectively, the relative availability of formulation B was 87.5% and 89.6% and the relative availability of formultation A was 43% and 35% when compared to formulation C(the standard).

• Archives of Pharmacal Research
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• v.28 no.8
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• pp.977-982
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• 2005

The aim of this study was to compare two formulations of film-coated pellets containing c1arithromycin after single oral dose study in healthy male volunteers. Two formulations with different coating polymers were prepared: formulation-1 (F-1) was prepared by incorporating three kinds of pH-dependent gradient-release coated pellets into capsules and formulation-2 (F-2) was prepared by coated with an insoluble semiosmotic film. Release profiles of filmcoated pellets were evaluated using paddle method under different conditions. Pharmacokinetic profiles of these formulations were obtained in three healthy male volunteers and compared to commercially available immediate release (IR) tablets. The relative bioavailability based on the $AUC_{0-24h}$ was found to be $96.2\%\;and\;58.7\%$ for F-1 and F-2 compared with IR, and the $T_{max}$ was delayed.