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올메살탄 메독시밀 제제의 생물학적 동등성과 용량 비례성에 관한 연구
조성권,김춘옥,유수현,오은실,장성복,박융식,조경희,정재용,Cho, Sung Kweon,Kim, Choon Ok,Yu, Su Hyun,Oh, Eun Sil,Jang, Seong Bok,Park, Yoong Sik,Cho, Kyunghee,Chung, Jae-Yong 대한임상약리학회 2012 臨床藥理學會誌 Vol.20 No.2
Background: Olmesartan medoxomil is an angiotensin II receptor blocker commonly used in hypertension. First objective of this study was to evaluate the bioequivalence of two olmesartan formulations, Olmesartan 20 mg and 40 mg tablet (Yuhan, Pharmaceutical Corp. Seoul, Korea) as test drugs and $Olmetec^{(R)}$ 20 mg and 40 mg tablet (Daewoong, Pharmaceutical Corp. Seoul, Korea) as reference drugs. Second objective of this study was to evaluate the dose-proportionality of two formulations. Methods: Two studies (20 mg, 40 mg) were conducted as a randomized, open-label, 2-period, crossover design. Each subject received one 20 mg or 40 mg tablet of the reference or test formulation of olmesartan medoxomil in each study. Blood samples were obtained during the 48-hour period after the dose in each treatment period. Wash-out period was 1 week in each study. Concentrations of olmesartan medoxomil in plasma were analyzed using a liquid chromatography system with tandem mass-spectrometric detection (LC/MS/MS). The primary pharmacokinetic parameters were $C_{max}$ (maximum concentration) and $AUC_t$ (area under the concentration-time curve from time 0 to the last sampling time). Results: A total number of 40 healthy male volunteers participated in the study and 37 volunteers completed both treatment periods in 20 mg trial. All 40 participants completed both treatment periods in 40 mg trial. The 90 % CIs for the geometric mean ratios of the pharmacokinetic parameters (test:reference drug) were 0.93 ~ 1.04 for $AUC_t$ and 0.97 ~ 1.08 for $C_{max}$ in 20 mg trial. The 90 CIs were 0.94 ~ 1.02 for $AUC_t$ and 1.00 ~ 1.11 for $C_{max}$ in 40 mg trial. All parameters of two studies satisfy the range of bioequivalence criterion. Conclusion: The obtained results indicated that pharmacokinetic exposure to Olmesartan 20 mg and 40 mg tablet was bioequivalent to that of $Olmetec^{(R)}$ 20 mg and 40 mg tablet, respectively.
신상아 (Shin,Sangah ),최슬기 (Choi,Seul Ki ),김혜미 (Kim,Hyemi ),이경윤 (Kyung Youn ),신상희 (Shin,Sanghee ),이정원 (Lee,Jung Won ),유수현 (Yu,Soo Hyun ),남혜선 (Nam,Hye-Soen ),윤혜정 (Yoon,Hae-Jung ),정효지 (Joung,Hyojee ) 韓國營養學會 2011 Journal of Nutrition and Health Vol.44 No.1
The aim of this study was to develop a reliable dietary questionnaire to assess human exposure to food-borne hazards. Eleven food-borne hazards were chosen as a priority control list through a literature review and advisory committees. The 11 food-borne hazards were phthalate, aflatoxin, bisphenol A, polycyclic aromatic hydrocarbons, dioxin, polychlorinated biphenyls, mercury, lead, cadmium, arsenic, and acrylamide. The characteristics, exposure level, and paths of these hazards were reviewed, and questionnaire items were identified to assess human exposure from the literature. A questionnaire was developed for each selected food based on its characteristics. Based on the items in the individual questionnaires, a comprehensive questionnaire, which contained demographic characteristics, job information, socioeconomic factors, health related lifestyles, and dietary behaviors, was developed. A 99-item food frequency questionnaire (FFQ) to assess food-borne hazard exposure was also developed. The FFQ included frequency of food intake during the previous year, container type for purchasing and storing food, and cooking method. The questionnaire developed in this study could be applied to assess dietary factors during an exposure assessment of food-borne hazards in a large population. A validation study for the questionnaire is needed before applying it to surveys. (Korean J Nutr 2011 44(1): 61 ~ 73)
식품으로 인한 유해물질 노출조사를 위한 식생활 설문지의 타당도 평가
김혜미(Kim,Hyemi),최슬기(Choi,Seul Ki),신상아(Shin,Sangah),이경윤(Lee,Kyung Youn),신상희 (Shin,Sanghee ),이정원 (Lee,Jung Won ),유수현 (Yu,Soo Hyun ),남혜선 (Nam,Hye-Soen ),김미경 (Kim,Mi-Gyeong ),정효지 (Joung,Hyojee ) 韓國營養學會 2011 Journal of Nutrition and Health Vol.44 No.2
Assessing human exposure to food-borne hazards requires standardized assessment tools. The objective of this study was to validate a newly developed dietary assessment questionnaire to assess human exposure to food-borne hazards, which include dietary behavior and food consumption patterns such as eating frequency, types of food containers and cooking methods. A total of 216 adults were recruited for two questionnaire surveys (questionnaire 1 and 2) about 1 week apart with a 3 day diet record. Reproducibility was evaluated by comparing responses from questionnaires 1 and 2, and validity was checked by comparing responses from questionnaire 2 and the 3 day diet record. Comparisons were based on the percent agreement and Spearman’s rank correlation coefficient. The mean exact agreement of food containers at purchase between questionnaires 1 and 2 was 73.5%, for storing containers it was 71.9%, and for cooking methods it was 83.0%. The mean correlation coefficient for food intake frequency between questionnaires 1 and 2 was 0.71 (range, 0.50-0.83). The mean correlation coefficient of the food intake frequency between questionnaire 2 and the 3 day diet record was 0.21 (range, 0.04-0.48). The exact and adjacent agreement of food intake frequency quartile assessed by questionnaire 2 and the 3 day diet record was 65.4% (range, 51.0-82.1%). Although the correlation coefficient for food intake frequency between questionnaire 2 and the 3 day diet record was low, the exact and adjacent food intake frequency agreement was higher than 50% and reproducibility of the dietary behaviors exceeded 70%. Therefore, the questionnaire developed in this study could be applied to assess diets for the human exposure to food-borne hazards as a qualitative assessment in a large population. (Korean J Nutr 2011 44(2): 171 ~ 180)