• Title/Summary/Keyword: Healthy Volunteers

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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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    • 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).

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Evaluation of In-Vitro Dissolution and In-Vivo Absorption for Two Different Film-Coated Pellets of Clarithromycin

  • Zhang Xiang-rong;Chen Xiao-yan;Hu Lian-Dong;Tang Xing;Li San-Ming;Zhong Da-fang
    • 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.

Comparative bioavailability of synthetic vitamin C and Nutra-C (calcium ascorbate) in Korean healthy volunteers

  • Choi, Kyung-Mi;Hoon, Kim Man;Won, Hwang Tae;Kim, Jong-Dae;Park, Keum duck;Kim, Mi-Young;Jung, Young-Rim;Shin, Hye-Seoung
    • Analytical Science and Technology
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    • v.29 no.4
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    • pp.162-169
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    • 2016
  • The purpose of this study was to compare the relative bioavailability of synthetic Vitamin C and Nutra-C® (calcium ascorbate) using a randomized parallel pharmacokinetics study design. Under fasting conditions, 20 healthy volunteers were randomly allocated to receive a single oral dose (500 mg of ascorbic acid) of either synthetic Vitamin C or Nutra-C®. Fasting blood was collected pre-dose and 1, 2, 3, 4, 7 and 10 hr post-dose. The ascorbic acid content of human serum was determined using HPLC with ultraviolet detection. The fasting serum ascorbic acid concentrations of synthetic Vitamin C and Nutra-C® were 6.734 ± 2.09 ng/mL (n = 10) and 7.542 ± 2.96 ng/mL (n = 10), respectively. The bioavailability of Nutra-C® was significantly greater (128 %, p < 0.05) than that of the synthetic Vitamin C.

Bioabaibility of Oxytetracycline and Erythromycin stearate (Oxytetracycline과 Erythromycin Stearate의 생체유용성 검토)

  • Lim J.K.;Chung M.H.;Shin S.G.;Cha I.J.
    • The Korean Journal of Pharmacology
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    • v.13 no.1 s.21
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    • pp.1-6
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    • 1977
  • The physicochemical equivalencies of drugs are not usually correlate to the generic equivalencies of drugs and the generic equivalencies of drugs produced by different manufacturers or different formulations are being called in question frequently. The bioabailability of two formulations of oxytetracycline and erythromycin stearate were performed in healthy human volunteers. At the same time, the disintegration testes were performed with randomly sampled materials in question. For the biological evaluation of new oxytetracycline formulation; tablet(250mg), two-way cross over study in 10 healthy young volunteers was performed using oxytetracycline capsule (250mg) as reference, Erythromycin stearate (250mg) tablets and capsules produced by different manufacturers were compared in a two-way cross over study in 12 subjects with same manner of oxytetracyclines. oxytetracycline tablets showed somewhat slow disintegration rate, but appeared not statistical differences in serum concentrations from the reference, up to six hours after ingestion. Erythromycin stearate capsules disintegrated more rapidly than enteric coated tablets. Serum concentrations of capsules were more variable and markedly lower (P<.005 after 2hrs) than the enteric coated tablets. Rapid disintegration of capsules may result in destruction of active chemicals owing to the interaction with gastric acid and the above factor may contribute mainly to the low serum level after ingestion of capsules.

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

  • Bae, Jeong-Sook;Seong, Sol-Bee;Jang, So-Mang;Yoo, Chang-Hee;Lim, Young-Suk;Lee, Young-Mi;Park, Hae-Ryun;Lee, Kyung-Eun
    • Korean Journal of Community Nutrition
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    • v.24 no.4
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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.

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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