• 제목/요약/키워드: Korean healthy volunteers

검색결과 749건 처리시간 0.024초

Bioavailability of Digoxin Tablets in Healthy Volunteers

  • Lee, Chi-Ho;Park, Yun-Ju;Charies-D. Sands;Daniel-W. Jones;John-M. Trang
    • Archives of Pharmacal Research
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    • 제17권2호
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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).

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

  • 윤휘열;김정현;이은주;정수연;최선옥;김형기;권준택;강원구;권광일
    • 한국임상약학회지
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    • 제15권1호
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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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$17\beta$-estradiol의 고혈압 유도반응 억제와 인체적용 전기자극의 $17\beta$-estradiol 활성 증가 (The inhibition of Hypertension-related Response by $17\beta$-estradiol and the Increase of $17\beta$-estradiol Activity by Electrical Stimulation)

  • 김중환
    • The Journal of Korean Physical Therapy
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    • 제21권2호
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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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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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    • 제27권2호
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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.

농촌 고령자 대상 농한기 마을 공동식사 프로그램 참여 조리자원봉사자의 프로그램 운영에 대한 인식과 과정 평가 (Operation and Process Evaluation of a Community Meal Program for the Elderly in Rural Areas during Agricultural Off-Season Perceived by Cooking Volunteers)

  • 배정숙;성솔비;장소망;유창희;임영숙;이영미;박혜련;이경은
    • 대한지역사회영양학회지
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    • 제24권4호
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    • pp.277-289
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    • 2019
  • Objectives: This study examined the practices of a community meal program for older adults in rural areas during the agricultural off-season. Methods: A survey was conducted from December 12 to December 22, 2016. Self-administered questionnaires were distributed to 150 cooking volunteers, who had participated in the community meal program in 50 villages. A total of 114 responses were returned from 44 villages and used for data analysis. In addition, in-depth interviews were conducted with the volunteers of eight villages. Results: Most of the cooking volunteers were 50 years old or older and they participated in serving older adults meals for good will. The cooking volunteers perceived that the older adults in their community did not eat various foods, had difficulties in grocery shopping, and frequently consumed salty foods. During the agricultural off-season, 40.9% of villages served the older adults meals 6-7 days a week and 95.5% provided meals for lunch. An average of 21 to 40 older adults were served meals in each village. The cooking volunteers reported that the food preparation and meal service times were sufficient, recipes provided were useful, and menus met the preference of the older adults. At the end of the program, they felt proud of serving meals for older adults in the community. An increased awareness of healthy eating, interest in health, and consumption of nutritious meals, a decrease in loneliness among older adults, and the promotion of fellowship in the community were rated highly. The cooking volunteers expected additional support for cooking personnel and insisted that the program should be provided for the entire agricultural off-seasons. Conclusions: The community meal program during the agricultural off-season for the elderly in rural areas was effective in improving the dietary life of older adults, relieving their feelings of isolation, and promoting fellowship of the community. The volunteers felt workload due to a shortage of volunteers but answered that they were rewarded by helping older adults in their community.

Risperidone pharmacokinetics in relation to CYP2D6 and MDR1 in healthy male Korean subjects

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Suk;Baek, Seung-Hee;Lee, Yong-Bok
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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    • pp.238.2-239
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    • 2003
  • The purposes of this study were to evaluate the relationship between the genetic polymorphisms in CYP2D6*10 allele, MDR1 (exon 21 and 26) gene and risperidone pharmacokinetics in healthy male Korean subjects. A single dose of 2 mg risperidone tablet was given orally to 23 healthy male Korean volunteers. Blood samples were taken during the 12 hours after the dose. Serum concentrations of risperidone and 9-hydroxyrisperidone were measured using HPLC with UV detector. 23 subjects were genotyped for CYP2D6*10 allele, MDR1 G2677 T and C3435T by polymerase chain reaction-restriction fragment length polymorphism(PCR-RFLP). (omitted)

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

  • 박경호
    • Journal of Pharmaceutical Investigation
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    • 제27권4호
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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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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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    • 제35권5호
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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.

가족자원봉사 프로그램개발과 만족도에 관한 연구: "새싹으로 나누는 사랑, 함께하는 기쁨" 프로그램과 참여자를 중심으로 (Study in Development and Satisfaction of the Family Volunteer Activity Program: Focused on "Sharing Love and Joy with Growing Sprouts" Program and the Participants)

  • 김혜령;정민자
    • 대한가정학회지
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    • 제49권2호
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    • pp.51-62
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    • 2011
  • The purpose of this study was to develop field programs to activate family volunteering and thereby promote healthy family life. The programs were based on a review of family ecological theories of family volunteering activities. A focus group interview was conducted about satisfaction of the program with five volunteers who were experiencing the same family life cycle. The results of study showed that growing sprouts, which are environmentally friendly activities in family, and family volunteer activities lead to family leisure, table, community sharing cultures and cooperation culture between the family and the community. These effects can ultimately contribute to the creation of a healthy family culture.

건강한 한국인 피험자에서 Entecavir 1 mg 제제의 약동학적 특성 평가 (Pharmacokinetic Propertiese of Entecavir 1 mg in Korean Healthy Volunteers)

  • 전지영;황민호;임용진;김윤정;한수미;임성혁;채수완;김민걸
    • 한국임상약학회지
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    • 제21권3호
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    • pp.224-227
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    • 2011
  • Entecavir is a potent and selective guanosine analogue that has demonstrated a significant antiviral efficacy against hepatitis B virus (HBV). The aim of this study was to evaluate the safety and pharmacokinetic profile after a single dose of entecavir 1 mg administration in Korean healthy male subjects. Eight volunteers were enrolled. After a single dose of 1 mg entecavir was orally administered, blood samples were collected at specific time intervals from 0-168 hours. The plasma concentrations of entecavir were determined by LC-MS/MS. The pharmacokinetic parameters were determined from the plasma concentration-time profiles. The mean values for $AUC_{last}$ and $AUC_{inf}$ were $14.84{\pm}7.81ng{\cdot}hr/mL$ and $20.71{\pm}8.80ng{\cdot}hr/mL$, respectively. The mean value for $C_{max}$ was $9.19{\pm}4.91ng/ml$ and median value for $t_{max}$ was 0.58 hr. No adverse events were reported by subjects or found on analysis of vital signs or laboratory tests. The results are suggested to be useful in clinical trials of entecavir in Korean subject including bioequivalence study.