• Archives of Pharmacal Research
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• v.28 no.4
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• pp.488-492
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• 2005

The purpose of this study is to investigate the bioequivalence of two haloperidol 5 mg tablets, Myung In haloperidol (Myung In Pharm. Co., Ltd., test drug) and $Peridol^{R}$(Whanin Pharm. Co., Ltd., reference drug), and also to estimate the pharmacokinetic parameters of haloperidol in Korean volunteers. The bioavailability and pharmacokinetics of haloperidol tablets were examined on 24 healthy volunteers who received a single oral dose of each preparation in the fasting state in a randomized balanced 2 way crossover design. After an oral dosing, blood samples were collected for a period of 60 h. Plasma concentrations of haloperidol were determined using a liquid chromatographic electrospray mass spectrometric (LC-MS) method. The pharmacokinetic parameters were calculated with noncompartmental pharmacokinetic analysis. The geometric means of $AUC_{0-60h} and C_{max}$ between test and reference formulations were $17.21\pm8.26 ng\cdot/mL vs 17.31\pm13.24 ng\cdot/mL and 0.87\pm0.74 ng/mL vs 0.85\pm0.62 ng/mL$. respectively. The $90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-60h} and C_{max} were log0.9677{\sim}log1.1201 and log0.8208{\sim}log1.1981$, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug. The geometric means of other pharmacokinetic parameters ($AUC_{inf}. t_{1/2}, V_{d}/F, and CL/F$) between test drug and reference drug were $21.75\pm8.50 ng{\cdot}h/mL vs 21.77\pm15.63 ng{\cdot}h/mL, 29.87\pm8.25 h vs 29.60\pm7.56 h, 11.51\pm5.45 L vs 12.90\pm6.12 L and 0.26\pm0.09 L/h vs 0.31\pm0.17 L/h$, respectively. These observations indicate that the two formulation for haloperidol was bioequivalent and, thus, may be clinically interchangeable.

• Korean Journal of Clinical Laboratory Science
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• v.41 no.4
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• pp.196-207
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• 2009

For the estimation of prevalence state of major chronic adult disease and their relationships with drinking and smoking habits in the Korean employees, we analyzed a medical check-up data of 155,799 subjects that was accumulated during the year of 2008. In age and sex distribution of the sample, male subjects were 106,229 and female 51,827 showing the ratio of 2:1 and the majorities were 30s and 40s covering 70.7% of the total. The prevalence rates of major chronic diseases were obesity 29.8% (male 38.3%, female 12.3%), hypertension 4.1%, HBV carrier inactive 3.3%, diabetes mellitus 2.9%, hypothyroidism 1.7% (male 1.3%, female 2.4%), hyperlipidemia 1.1%, hyperthyroidism 1.4% (male 1.1%, female 2.1%), osteoporosis 1.4% (male 1.4%, female 1.4%), anemia 0.9% (male 0.3%, female 2.0%) and renal disease 0.9%. The frequency of and volume of drinking in male group were 4.6 times and 7.5 times higher than female group respectively. The 33.8% of the workers were smoking currently. In the serological tests, all the items such as AST, ALT, ${\gamma}-GTP$, LDH for liver function, Cholesterol, TG, uric acid for hyperlipidemia and BP systolic, Fasting blood sugar, BMI for metabolic syndrome were significantly higher in the more drinking and more smoking groups than other groups (p<0.001). The higher prevalence rates in male group in the liver disease seems to be strongly related with the drinking and smoking habits in male employees. We suggest that employees should rather relying on leisure or hobbies than drinking and smoking for the stress relief.

• Korean Journal of Clinical Pharmacy
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• v.8 no.1
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• pp.19-22
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• 1998

Cefixime is an orally absorbed 3rd generation cephalosporin with a broad spectrum of activity against Gram-positive and Gram-negative bacteria and is highly resistant to $\beta-lactamase$ degradation. This study was carried out to evaluate the bioavailability of a new test drug of cefixime (100 mg/capsule) relative to the reference drug. The bioavailability was conducted on 20 healthy volunteers who received a single dose (400 mg) of the test and the reference drugs in the fasting state, in a randomized balanced 2-way crossover design. After dosing, serial blood samples were collected for a period of 12 hours. Plasma was analyzed for cefixime by a sensitive and validated HPLC assay. The major pharmacokinetic parameters $(AUC_{0-12hr},\;C_{max},\;T_{max})$ were calculated from the plasma concentration-time data of each volunteer. The $AUC_{0-12hr},\;C_{max}\;and\;T_{max}$ of the test drug were $36.91\pm11.85\;{\mu}g{\cdot}hr/ml,\;5.47\pm1.61\;{\mu}g/ml,\;and\;4.00\pm0.65\;hr,$ respectively, and those of the reference drug were $34.08\pm8.81\;{\mu}g{\cdot}hr/ml,\;5.25\pm1.40\;{\mu}g/ml,\;and\;4.20\pm0.62\;hr$, respectively. Mean differences of those parameters were 8.32, 4.29, and $4.76\%$, respectively, and the least significant differences at $\alpha$=0.05 for $AUC_{0-12hr},\;C_{max},\;T_{max}$ were 16.02, 13.78, and $11.76\%$, respectively. In conclusion, the test drug was bioequivalent with the reference drug.

• Korean Journal of Clinical Pharmacy
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• v.19 no.1
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• pp.23-31
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• 2009

The aim of this study was to evaluate the pharmacokinetic parameters of two risedronate preparations. The clinical assessment was conducted on 46 healthy volunteers who received one tablet (Risedronate sodium 35 mg/tablet) in the fasting state, in a randomized balanced $2{\times}2$ cross-over study design. After dosing of one tablet containing 35 mg risedronate sodium, blood samples were collected serially for a period of 48 hours. Plasma was analyzed for risedronate by using LC/MS/MS assay method. The analysis system was validated in specificity, accuracy, precision, and linearity. $AUC_t$, (the area under the plasma concentration-time curve from the zero-time to 48 hr) was calculated through the trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) were compiled from the plasma risedronate concentration-time data of each volunteer. No significant sequence effect was found for the pharmacokinetic parameters indicating that the cross-over design was properly performed. The 90 % - Confidence intervals of the $AUC_t$ ratio and the $C_{max}$ were from log 0.8752 to log 1.1888 and log 0.8457 to log 1.1478, respectively. These values were within the acceptable intervals between 0.80 and 1.25. Therefore, this study demonstrated that no statistically significant difference was identified with respect to the rate and extent of absorption.

• The Korean Journal of Physiology
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• v.16 no.1
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• pp.57-61
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• 1982

This study was conducted to investigate the effect of ingestion of rice meal with red pepper(Capsicum annuum) as a seasoning upon the plasma gastrin concentration of normal human subjects in Korea. Thirteen normal human subjects including male and female(mean age: 21 years, range: $20{\sim}24\;years$) were studied. After an overnight(about 15 hrs) fast each subject ingested a test meal and a control meal on different days. The test meal consisted of 250 g toiled rice, 250 ml radish soup containing red pepper(dried powder, 3 g), 50 g vegetables and 200 ml barley tea, corresponding to 7.0 g protein, 9.0 g fat and 82 g carbohydrate and the control meal consisted of the same amount as the test meal except that the radish soup was supplied without red pepper. The venous blood samples were drawn before and after the ingestion of meals at the following times: -30, 0, 15, 30, 45, 60, 90, and 120 min for the measurement of plasma gastrin concentration by means of radioimmunoassay. 1) Plasma gastrin concentration in response to the ingestion of control meal without red pepper increased significantly compared with the concentration in fasting state. 2) The increase of plasma gastrin concentration after the ingestion of test meal(containing red pepper) was significantly higher than that after the control meal. It is inferred from the above mentioned results that the ingestion of red pepper as a seasoning has a stimulatory influence on gastrin release in normal human subjects.

• Journal of Physiology & Pathology in Korean Medicine
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• v.19 no.2
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• pp.530-535
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• 2005

A Korean traditional herbal formular, Taeumbiman-tang(TBT), was based on Taeumjowi-tang, currently the most widely used herbal formula compound, and which is known to be safe and have a positive effect on adult obesity. TBT was given to obese children for thirty days, and was found to be clinically safe and effective. The subjects were children who had been admitted into the hospital to be treated for obesity, that had more than 20% relative body weight. Originally there were 19 subjects, but 5 dropped out of the experiment. There were 5 girls and 9 boys, whose average ages were $11.00\;{\pm}\;2.60$ years, average weight was $54.01\;{\pm}\;18.59\;kg$. As a pretest, all of the volunteers were examined for height, weight, blood pressure, pulse rate, EKG, and chest radiography. The subjects underwent interview, body measurement tests, blood tests, and safety tests under 8 hour fasting state. After 15 days of TBT intake, the safety tests and the interview were conducted. The interview, body measurement tests, blood tests, and safety tests were conducted again after the 30 day trial was completed. The short term effects of TBT on obese children is weight loss. It did not cause any significant changes in the subject's livers, hearts, and kidneys, and clinically dangerous side effects or withdrawal symptoms were not observed.

• Korean Journal of Community Nutrition
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• v.9 no.3
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• pp.292-302
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• 2004

The nutritional status of middle-aged overweight and control normal subjects were evaluated for the purpose of providing the background information of the degenerative disease control. A survey was conducted with 293 healthy subjects (121 males and 172 females) between the ages 40-64. The average BMI (body mass index) of male subjects was 24.5 $\pm2.75$, and that of females was 23.5 $\pm2.87$. The average values of WHR (waist-hip ratio) were 0.88 $\pm0.04$, for males and 0.82 $\pm0.07$, for females. The normal BMI group (BMI 18.5-22.9) comprised 28.9% of males and 47.1% of females. The percentage of overweight subjects (BMI 23-24.9) was 26.4% of males and 30.8% of females. The obese group (BMI ＞ 25) was 44.6% of males ana 22.1% of females, showing the greater rate of obese state among male subjects. The average energy intakes were 76.6 $\pm14.9$% for males and 77.8 $\pm12.6$, % for females, protein intakes were 108.0 $\pm24.6$% for males and 111.2 $\pm22.7$, % for females of the RDA levels. The average intakes of other nutrients were above the 75% of RDA levels except calcium. The average nutrient intakes of the three subgroups according to their BMI values were not different for both males and females. There were weak correlations between obesity and blood biochemical indices. There were positive correlations between BMI or WHR and hemoglobin, hematocrit, fasting glucose, total cholesterol, triglyceride, AST or ALT. There were negative correlations between BMI or WHR and HDL-cholesterol. These results suggest that the obesity rate of middle-aged is an influential factor of chronic disease. The middle-aged subjects of this study with higher educational and socioeconomic background tend to have desirable nutrition knowledge and attitude, but the application of their knowledge or attitude was relatively poor.

• Journal of Nutrition and Health
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• v.23 no.6
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• pp.451-458
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• 1990

Lean and obese male spontaneously hypertensive(SHR/Mcc-cp) rats were fed a ground rat chow diet with or without 0.001% estrone added from 6 to 18 weeks of age. Urine samples were collected weekly with 24 hour fasting. Both control lean and obese rats showed significantly higher urinary protein than their estrone treated counterparts. Treatment with 0.001% estrone diet was found to reduced the proteinuria in the maturing lean and obese SHR/Mcc-cp rats. Peaks in urinary protein level were noted at 16 weeks of age in both lean and obese control rats. Both control and estrone treated lean rats showed higher proteinuria than the obese rats. Therefore, obesity does not appear to be a contributing factor to the proteinuria in young male SHR/Mcc-cp rats.

• Archives of Pharmacal Research
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• v.27 no.7
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• pp.806-810
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• 2004

Metformin is a biguanide antihyperglycemic agent often used for the treatment of non-insulin dependent diabetics (NIDDM). In this study, the pharmacokinetics and pharmacodynamics of metformin were investigated in Korean healthy volunteers during a fasting state for over 10 h. In order to evaluate the amount of glucose-lowering effect of metformin, the plasma concentrations of glucose were measured for a period of 10 h followed by the administration of metformin (oral 500 mg) or placebo. In addition, the concentration of metformin in blood samples was determined by HPLC assay for the drug. All volunteers were consumed with 12 g of white sugar 10 minutes after drug intake to maintain initial plasma glucose concentration. The time courses of the plasma concentration of metformin and the glucose-lowering effect were analyzed by nonlinear regression analysis. The estimated $C_{max}$, $T_{max}$, $CL_{t}$/F (apparent clearance), V/F(apparent volume of distribution), and half-life of metformin were 1.42$\{pm}$0.07 $\mu\textrm{g}$/mL, 2.59$\{pm}$0.18h, 66.12$\{pm}$4.6 L/h, 26.63 L, and 1.54 h respectively. Since a significant counterclock-wise hysteresis was found for the metformin concentration in the plasma-effect relationship, indirect response model was used to evaluate pharmacodynamic parameters for metformin. The mean concentration at half-maximum inhibition $IC_{50}$, $k_{in}$, $k_{out}$ were 2.26 $\mu\textrm{g}$/mL, 83.26 $H^{-1}$, and 0.68 $H^{-1}$, respectively. Therefore, the pharmacokinetic-pharmacodynamic model may be useful in the description for the relationship between plasma concentration of metformin and its glucose-lowering effect.

• The Korean Journal of Physiology and Pharmacology
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• v.27 no.1
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• pp.9-20
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• 2023

The mechanism is unclear for the reported protective effect of hyperbaric oxygen preconditioning against oxidative stress in tissues, and the distinct effects of hyperbaric oxygen applied after stress. The trained mice were divided into three groups: the control, hyperbaric oxygenation preconditioning, and hyperbaric oxygenation applied after mild (fasting) or hard (prolonged exercise) stress. After preconditioning, we observed a decrease in basal levels of nitric oxide, tetrahydrobiopterin, and catalase despite the drastic increase in inducible and endothelial nitric oxide synthases. Moreover, the basal levels of glutathione, related enzymes, and nitrosative stress only increased in the preconditioning group. The control and preconditioning groups showed a similar mild stress response of the endothelial and neuronal nitric oxide synthases. At the same time, the activity of all nitric oxide synthase, glutathione (GSH) in muscle, declined in the experimental groups but increased in control during hard stress. The results suggested that hyperbaric oxygen preconditioning provoked uncoupling of nitric oxide synthases and the elevated levels of GSH in muscle during this study, while hyperbaric oxygen applied after stress showed a lower level of GSH but higher recovery post-exercise levels in the majority of antioxidant enzymes. We discuss the possible mechanisms of the redox response and the role of the nitric oxide in this process.