• Title/Summary/Keyword: Healthy volunteers

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Effect of Food on Pharmacokinetics and Pharmacodynamics of Fenofibric Acid after a Single Oral Dose of Fenofibrate Sustained-Release Capsule (식단에 따르는 페노피브레이트 서방성 캡슐의 1회 경구 투여 후 약물동태학 및 약물동력학의 평가)

  • Yun, Hwi-yeol;Kim, Joung-hyun;Lee, Eun Joo;Chung, Soo Youn;Choi, Sun-oK;Kim, Hyung Kee;Kwon, Jun-tack;Kang, Wonku;Kwon, Kwang-il
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.1
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    • pp.34-40
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    • 2005
  • We examined the effects of food on pharmacokinetic and pharmacodynamic properties of fenofibrate released from sustained-release(SR) capsule as therapy for hypolipidemia. Twenty-four healthy volunteers were used in $3{\times}3$ crossover pharmacokinetic and pharmacodynamic study; Additional six volunteers were used as a control group (i.e., no fenofibrate administration). A single dose of fenofibrate (SR capsule, 250 mg) was administered on three occasions: after overnight fasting, after consumption of a standard breakfast, and after a high-fat breakfast. Serial blood samples were collected for the next 72 hours. Plasma fenofibric acid concentrations were measured by high performance liquid chromatography, and pharmacokinetic parameters were calculated using ADAPT II program. Plsama triglyceride concentrations were measured by blood chemistry analyzer (CH-100). The pharmacokinetic parameters were significantly affected by food intake. The high-fat breakfast affected the rate of absorption of fenofibrate more than did the standard breakfast and fasted conditions. Plasma concentrations of triglyceride at 24 hours decreased significantly after the administration of fenofibrate compared with the concentration at 0 hours(P<0.05). In healthy volunteers, the bioavailability of fenofibrate was greater when administered via sustained-release capsules immediately after the consumption of food than after fasting condition.

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Evaluations on Salivary Flow Induction and Dissolution Patterns in Saliva of Pilocarpine Chewing Tablet in Healthy Human Volunteers (건강한 성인 지원자를 대상으로 한 필로칼핀 저작정의 타액분비 유도 및 타액중 용출패턴 평가)

  • Park, Kyoung-Ho
    • Journal of Pharmaceutical Investigation
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    • v.27 no.4
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    • pp.331-335
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    • 1997
  • Xerostomia is caused by organic or functional changes affecting the salivary system at different levels. Patients suffering from xerostomia may also complain of an oral burning sensation, ulceration or soreness, difficulty in swallowing, and poor denture retention. And pilocarpine is administered orally to induce salivary secretion. In Seoul National University Hospital(SNUH) pharmacy, the pilocarpine chewing tablets are prepared and supplied to patients of xerostomia in request of the dental hospital in SNUH. And we tested the salivary flow induction and the dissolution patterns of these products in saliva by a double-blind, sequential cross-over trials to eight healthy human volunteers with placebo. The pilocarpine chewing tablet contained 5 mg of pilocarpine, and placebo consisted of same materials as test drug, but didn't contain pilocarpine. In vivo experiment, all subjects were instructed to chew as 60-80 times/min. Mixed saliva was collected in the ranges of intervals such as 0-2, 2-5, 5-10, 10-15, 15-20, 20-30, 30-45 and 45-60 min after pilocarpine chewing tablet or placebo administration. Saliva volume was measured in each collecting time interval, and saliva pilocarpine concentrations were determined by reversed phase HPLC. The 82.5 percent $(4.13{\pm}0.69\;mg)$ of pilocarpine was extracted from chewing tablets during mastication of 60-80 times per minute for 60 minutes. Among these dissolved amounts, 90 percent was extracted within 20 minutes. The salivary flow rates were more increased in a group who administered pilocarpine chewing tablet at the interval of 5-10, 10-15, 20-30 and 45-60 min rather than a placebo-group, but only extracted amount of pilocarpine at 45-60 min interval is significanly different between two groups (p<0.05). But total amounts of saliva secreted for 1 hour in two group-pilocarpine and placebo treated- were $46.36{\pm}9.72\;ml\;and\;39.09{\pm}7.81\;ml$, respectively, and were not significantly different between two groups.

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Physiological variations in the autonomic responses may be related to the constitutional types defined in Ayurveda

  • Rapolu, Sunil Buchiramulu;Kumar, Manoj;Singh, Girish;Patwardhan, Kishor
    • CELLMED
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    • v.5 no.1
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    • pp.7.1-7.7
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    • 2015
  • According to Ayurveda, an individual can be classified into any one of the seven constitutional types (Prakriti) depending on the dominance of one, two, or three Doshas. A 'Dosha' is representative of fundamental mechanisms that are responsible for homeostasis, and thus, to health. In the recent years, there have been several efforts to see whether certain physiological, haematological or biochemical parameters have any relationship with the constitutional types or not. The objective of the present study was to see if the results of autonomic function tests vary according to Prakriti of an individual. We conducted this study in clinically healthy volunteers of both the gender belonging to the age group of 17 to 35 years after obtaining their written consent. The Prakriti of these volunteers was assessed on the basis of a validated questionnaire and also by traditional method of interviewing. After confirming that the primary Dosha ascertained by both these methods matched, 106 volunteers were grouped into three on the basis of primary Dosha and were subjected to various autonomic function tests such as cold pressor test, standing-to-lying ratio, Valsalva ratio and pupillary responses such as pupil cycle time and pupil size measurement in light and dark. The results suggest that, the autonomic function tests in the healthy individuals may correlate linearly with the primary Dosha expressed in an individual. In particular, people with Kapha as the most dominant Dosha showed a tendency to have either a higher parasympathetic activity or a lower sympathetic activity with respect to their cardiovascular reactivity in comparison to the individuals with Pitta or Vata as the most dominant Dosha.

Bioavailability Test of TestoTM Tablets (Methyltestosterone, 25 mg) in Male Healthy Volunteers by a Gas-chromatography/Mass Selective Detector

  • Kwon, Oh-Seung;Kim, Hye-Jung;Pyo, Hee-Soo;Kim, Dae-Duk;Chung, Youn-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.5
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    • pp.383-388
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    • 2005
  • A simple and specific method for determination of methyltestosterone (MT) has been established by a gas chromatography/mass selective detector and applied in plasma of healthy male volunteers received a single oral dose of 50 mg MT $(Testo^{TM}\;tablets,\;25\;mg)$ for bioavailability test. This method involves using liquid-liquid extraction of the sample with diethyl ether and derivatization with MSTFA. MT showed good resolution in this condition. The detection limit of quantitation was 5 ng/ml. A good linearity (r>0.996) was obtained at the range of 5-250 ng/ml of MT. Intra-day precision and accuracy were 2.76-12.56% and 0.39-8.01 %, and inter-day precision and accuracy were 2.29-17.69% and 0.42-7.99%, respectively. The established method was applied on bioavailability test of MT in human volunteers. The value of $AUC_{0\;to\;last}$ to last was $264.5{\pm}123.9\;ng{\cdot}hr/ml$ and that of $AUC_{0\;to\;inf}$ was determined to be $275.2{\pm}126.5\;ng{\cdot}hr/ml$. The values of $C_{max}$ and $T_{max}$ were $95.9{\pm}67.1\;ng/ml$ and $1.13{\pm}0.9\;hr$, respectively. The mean elimination half-life $(t_{1/2})$ was $4.4{\pm}0.9\;hr$. This analytical method is suitable and useful for the pharmacokinetics and bioequivalence studies of MT.

The inhibition of Hypertension-related Response by $17\beta$-estradiol and the Increase of $17\beta$-estradiol Activity by Electrical Stimulation ($17\beta$-estradiol의 고혈압 유도반응 억제와 인체적용 전기자극의 $17\beta$-estradiol 활성 증가)

  • Kim, Jung-Hwan
    • The Journal of Korean Physical Therapy
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    • v.21 no.2
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    • pp.109-116
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    • 2009
  • Purpose: $17\beta$-estradiol is the most active endogenous estrogen, which is related to favorable changes in the plasma lipid profile, to relaxation of the coronary vessels, and to a decrease in platelet aggregation and vascular smooth muscle cell migration. However, although the beneficial effect of estrogens on plasma lipoproteins (ie, lowering low-density lipoprotein and increasing high-density lipoprotein cholesterol) contributes to cardiovascular protection, it does not fully account for the protective effect, particularly in the application of physical therapy, including low frequency electrical stimulation. Methods: The aim of this study was to demonstrate the inhibition of stressors, such as endothelin-1 (ET-1), serotonin (5-hydroxytryptamine, 5-HT), prostaglandin $F2\alpha$ ($PGF2\alpha$), and a protein kinase C (PKC) activator 12-deoxyphorbol 13-isobutyrate (DPB), induced isometric tension by $17\beta$-estradiol in vascular smooth muscle strips, respectively. In addition, the effects of low frequency electrical stimulation at the meridian points (CV-3, -4, Ki-12, SP-6, LR-3, BL-25, -28, -32, -52) on the indirect antihypertensive effect were examined by monitoring the changes in the serum $17\beta$-estradiol concentration in healthy volunteers. Results: Isometric tension analysis showed that the responses of inhibited tension by $17\beta$-estradiol were similar to the same stressors in rat aortic smooth muscle strips. Furthermore, although the continued amplitude modulation (AM) type of electrical stimulation was not increased significantly by electrical stimulation, the current of the frequency modulation (FM) type of low frequency electrical stimulation increased the serum $17\beta$-estradiol concentration in normal volunteers. Conclusion: These results, in part, suggest that $17\beta$-estradiol has the capacity to supress stressor-induced muscle tension, and electrical stimulation, particularly current of the FM type, has a modulatory effect on the sex steroid hormones, particularly $17\beta$-estradiol, in healthy volunteers.

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Bioequivalence Evaluation of Two Atenolol Tablet Preparations in Korean Healthy Male Volunteers

  • Gwak, Hye-Sun;Chun, In-Koo
    • Biomolecules & Therapeutics
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    • v.15 no.3
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    • pp.187-191
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    • 2007
  • This study was conducted to compare the bioavailability of two brands of atenolol (50 mg) tablets, which are a generic product of $Ditent^{\circledR}$ (Daewon Pharmaceutical Co., Ltd., Korea) and an innovator product $Tenormin^{\circledR}$ (Hyundai Pharm. Ind. Co., Ltd., Korea), in 20 healthy Korean male volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way cross-over design. The washout period between treatments was 1 week. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs. time curves, the following parameters were compared: area under the plasma concentration-time curve ($AUC_{0-24}$), peak plasma concentration ($C_{max}$), time to reach peak plasma concentration ($T_{max}$), and terminal first order elimination half-life ($t_{1/2}$). No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed $AUC_{0-24}$ and $C_{max}$ values of the two products. The 90% confidence interval for the ratio of the logarithmically transformed AUC and $C_{max}$ values of $Ditent^{\circledR}$ over those of $Tenormin^{\circledR}$ were calculated to be between 0.85 and 1.04, and 0.89 and 1.07, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ group was 3.1 hour, and that in Ditent$^{\circledR}$ group was 3.2 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean values were 5.2 hour in the both products. Based on these results, it was concluded that $Ditent^{\circledR}$ was comparable to $Tenormin^{\circledR}$ in both the rate and extent of absorption, indicating that $Ditent^{\circledR}$ was bioequivalent to the reference product, $Tenormin^{\circledR}$.

Survey of Sonoanatomic Distances For Lumbar Medial Branch Nerve Blocks in Healthy Volunteers

  • Gharaei, Helen;Imani, Farnad;Solaymani-Dodaran, Masoud
    • The Korean Journal of Pain
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    • v.27 no.2
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    • pp.133-138
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    • 2014
  • Background: The precise knowledge of anatomy and the region of transverse process (TP) and superior articular processes (AP) and their distance from the skin are important in blocking and treating lumbar facet syndrome. Evaluation of these anatomic distances from 3rd and 5th lumbar vertebrae in both sides and in different body mass index (BMI) in healthy volunteers might improve knowledge of ultrasound (US) lumbar medial branch nerve blocks (LMBB). Methods: Bilateral US in the 3rd and 5th lumbar vertebrae of 64 volunteers carried out and the distance between skin to TP and skin to AP was measured. These distances were compared on both sides and in different BMI groups. The analysis was done using SPSS 11. Analysis of variance was used to compare the means at three vertebral levels (L3-L5) and different BMI groups. P values less than 0.05 were considered statistically significant. The paired t-test was used to compare the mean distance between skin to TP and skin to AP on both sides. Results: The distance between skin to TP and skin to AP of 3rd vertebrae to 5th vertebrae was increased in both right and left sides (P < 0.001) from up to down. The mean distance from skin to TP were greater on the left side compared to the right in all three vertebral levels from L3 to L5 (P values 0.014, 0.024, and 0.006 respectively). The mean distance from skin to TP and the skin to AP was statistically significant in different BMI groups (P < 0.001). Conclusions: We found many anatomic distances which may increase awareness of US guided LMBB.

Diversity of Duodenal and Rectal Microbiota in Biopsy Tissues and Luminal Contents in Healthy Volunteers

  • Li, Gangping;Yang, Min;Zhou, Kan;Zhang, Lei;Tian, Lugao;Lv, Shangze;Jin, Yu;Qian, Wei;Xiong, Hanhua;Lin, Rong;Fu, Yu;Hou, Xiaohua
    • Journal of Microbiology and Biotechnology
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    • v.25 no.7
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    • pp.1136-1145
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    • 2015
  • The diverse microbial communities that colonize distinct segments of the gastrointestinal tract are intimately related to aspects of physiology and the pathology of human health. However, most recent studies have focused on the rectal or fecal microbiota, and the microbial signature of the duodenum is poorly studied. In this study, we compared the microbiota in duodenal and rectal samples to illustrate the characteristic microbial signatures of the duodenum in healthy adults. Nine healthy volunteers donated biopsies and luminal contents from the duodenum and rectum. To determine the composition and diversity of the microbiota, 454-pyrosequencing of bacterial 16S rRNA was performed and multiple bioinformatics analyses were applied. The α-diversity and phylogenetic diversity of the microbiota in the duodenal samples were higher than those of the rectal samples. There was higher biodiversity among the microbiota isolated from rectal biopsies than feces. Proteobacteria were more highly represented in the duodenum than in the rectum, both in the biopsies and in the luminal contents from the healthy volunteers (38.7% versus 12.5%, 33.2% versus 5.0%, respectively). Acinetobacter and Prevotella were dominant in the duodenum, whereas Bacteroides and Prevotella were dominant in the rectum. Additionally, the percentage of OTUs shared in biopsy groups was far higher than in the luminal group (43.0% versus 26.8%) and a greater number of genera was shared among the biopsies than the luminal contents. Duodenal samples demonstrated greater biological diversity and possessed a unique microbial signature compared with the rectum. The mucosa-associated microbiota was more relatively conserved than luminal samples.

Effect of Electroacupuncture Stimulation on Heart Rate Variability in Healthy Adults (전침 자극이 정상 성인의 심박변동에 미치는 영향)

  • Kim, Min-su;Kwak, Min-ah;Jang, Woo-seok;Rhie, Ki-tae;Jeong, Kee-sam;Jung, Tae-young;Seo, Jung-chul;Seo, Hae-gyoung;An, Hee-duk
    • Journal of Acupuncture Research
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    • v.20 no.4
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    • pp.157-169
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    • 2003
  • Objective : The effects of electroacupuncture(EA) stimulation on heart rate variability(HRV) for healthy adults are investigated with power spectrum analysis(PSA) of HRV. Methods : The HRVs of every 10 minute for 22 healthy volunteers(13 men and 9 women) were measured for an hour with SA-3000P(Medicore Co., Ltd., Korea). The median age with arithmetic range of 13 men and 9 women was 26.00 years with 22.75~27.00 years. The initial 20 minutes were defined as baseline period(pre-EA period), the following 20 minutes as the EA period and the last 20 minutes as the post-EA period. In each EA periods, volunteers received EA(2Hz, 0.6~0.8ms duration, maximal tolerated stimulation without discomfort) on the right Zusanli(ST36), Shangjuxu(ST37) acupoints while supine, resting. Results : Heart rate of volunteers at post-EA period was significantly decreased compare to that of pre-EA period, while SDNN at post-EA period was significantly increased. Heart rate at EA period was significantly decreased compare to that of pre-EA period, but Ln(LF) and LF/HF at EA period were significantly increased. Ln(HF) at post-EA period was significantly decreased compare to that of EA period, while the other variables were not significantly changed. Conclusions : The results suggest that EA in healthy adults is associated with changed activity in the sympathetic and parasympathetic nervous system. Further study is needed for investigating the effects of EA on HRV and autonomic nervous system.

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The Effect of an Educational Intervention on Health Literacy and the Adoption of Nutritional Preventive Behaviors Related to Osteoporosis Among Iranian Health Volunteers

  • Dehghankar, Leila;Panahi, Rahman;Hasannia, Elham;Hemmati, Fatemeh;Siboni, Fatemeh Samiei
    • Journal of Preventive Medicine and Public Health
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    • v.54 no.6
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    • pp.404-411
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    • 2021
  • Objectives: Given the increase in osteoporosis among health volunteers and the effect of health literacy on the adoption of nutritional preventive behaviors, this study aimed to determine the effects of an educational intervention on health literacy and the adoption of nutritional preventive behaviors related to osteoporosis among health volunteers. Methods: This was a quasi-experimental, interventional study of health volunteers conducted in 2020. In this study, 140 subjects (70 in both intervention and control groups) were selected using the random multi-stage sampling method. An educational intervention was conducted using the Telegram application, and educational messages were sent to the health volunteers in the intervention group across 6 sessions. Data were collected via a demographic questionnaire, the Health Literacy for Iranian Adults survey, and a nutritional performance questionnaire, which were completed before and 3 months after the intervention. The data were collected and analyzed using SPSS version 23. Results: Before the intervention, there were no significant differences in the mean scores for health literacy variables and the adoption of nutritional preventive behaviors between the intervention and control groups (p>0.05). After the intervention, there was a significant change in the mean scores for health literacy and the adoption of preventive behaviors in the intervention group (p<0.05) as opposed to the control group. Conclusions: Interventions aimed at increasing health literacy are effective for promoting the adoption of preventive and healthy nutritional behaviors related to osteoporosis.