Pharmacokinetics of Indomethacin, a Metabolite of Acemetacin, Following a Single dose and Multiple doses Administered as Acemetacin Sustained-Release Tablets in Healthy Male Volunteers
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概要
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The objective of this study was to estimate the pharmacokinetics of the newly developed once-daily acemetacin sustained-release tablets compared with those of the commercial acemetacin sustained-release capsules. Ten male healthy Chinese volunteers were included in the study. The administration schedule was a randomized crossover design. Each volunteer received 90mg of the tablet or the capsule in the single-dose study, and each received 90 mg of the tablet or the capsule once daily for 6 consecutive days in the multiple-dose study. The areas under the concentration-time curve (AUC_<0-24hr>), maximal concentrations of indomethacin (C_<max>), time to reach peak concentration (T_<max>), and elimination half-life (T_<1/2>) values of indomethacin (an active metabolite of acemetacin) were 6.72±0.99μg.hr/ml, 0.82±0.08μg/ml, 4.2±0.6, and 10.1±4.2hr, respectively. The steady-state AUC_<120-144hr> and steady-state maximal concentration of the tablets increased to 10.33±1.06μg.hr/ml and 1.14±0.10μg/ml, respectively. The pharmackinetic parameters (AUC_<0-24hr>, C_<max>, T_<1/2>, and mean residence time) for two formulations were not significantly different but the average T_<max> of the tablets was delayed by 1 hr compared with that of the capsules (4.2±0.6 vs. 3.2±0.6 hr, p<0.05). The mean relative bioavailability of the tablets was 97.9±14.8% compared with that of the capsules. It could be concluded that the pharmacokinetic parameters of the newly developed sustained-release tablets are similar to those of the sustained-release capsules, excluding the T_<max> value. A significant correlation was obtained between the in vivo mean absorption rate and the in vitro mean dissolution rate for the newly developed sustained tablets.
- 社団法人日本薬学会の論文
- 2005-06-01
著者
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Wang Li
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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ZHANG Rui
Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
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Wang Gui
Department Of Pharmaceutics Peking University School Of Pharmaceutical Sciences
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WANG Jian
Department of Radiology and Center for Advanced Medical Technology, Nippon Medical School
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Wang Jian-cheng
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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Zhang Qiang
中華人民共和国
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Zhang Q
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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Zhang Q
School Of Pharmaceutical Sciences Peking University
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Zhang Qiang
Department of Hepatology, Capital University of Medical Science Affiliated Beijing You An Hospital
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Zhang Xuan
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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ZHANG Xuan
Department of Pharmaceutics, Peking University
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Li Dong
Department of Pharmaceutics, Peking University School of Pharmaceutical Sciences
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Lu Wan
Department of Pharmaceutics, Peking University School of Pharmaceutical Sciences
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Wang Xue
Department of Pharmaceutics, Peking University School of Pharmaceutical Sciences
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Zhang Hua
Department of Pharmaceutics, Peking University School of Pharmaceutical Sciences
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Zhang Rui
Department Of Pharmaceutics Peking University School Of Pharmaceutical Sciences
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Zhang Xuan
Department Of Human Genetics Graduate School Of Medicine University Of Tokyo
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Zhang X
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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Zhang Xuan
Department Of Pharmaceutics Peking University School Of Pharmaceutical Sciences
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Wang Jian-cheng
Department Of Pharmaceutics Peking University
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Lu Wan-liang
中華人民共和国
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Zhang Qiang
Department Of Cardiology Beijing Anzhen Hospital Capital Medical University
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Wang Xue
State Key Laboratory Of Natural And Biomimetic Drugs And School Of Pharmaceutical Sciences Peking Un
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Zhang Rui
Department Of Cardiology Rui Jin Hospital Shanghai Jiao Tong University School Of Medicine
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Li Dong
Department Of Pharmaceutics Peking University School Of Pharmaceutical Sciences
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Li Dong-mei
Department Of Control Science And Engineering Harbin Institute Of Technology
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Wang Jian
Department Of Computational Science National University Of Singapore
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Lu Wan-liang
Department Of Pharmaceutics School Of Pharmaceutical Sciences Peking University:state Key Laboratory
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Wang Xue
Department Of Pathology Shanghai Medical College Fudan University
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Li Dong
Department Of Clinical Pharmacy Shenzhen People's Hospital The Second Medical College Of Jinan
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Zhang Rui
Department Of Biology The Pennsylvania State University
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Zhang Hua
Department Of Cardiovascular Surgery Norman Bethune Medical University
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Wang Jian
Department Of Applied Biology & Chemical Technology The Hong Kong Polytechnic University
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Zhang Rui
Department Of Biochemistry And Molecular Biology Fourth Military Medical University
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Wang Jian
Department Of Analytical Chemistry China Pharmaceutical University
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Wang Xue-Qing
Department of Pharmaceutics, Peking University School of Pharmaceutical Sciences
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WANG Xue-Qing
Department of Paediatrics and Child Health, University of Queensland, Royal Children's Hospital
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