Pharmacokinetics, Pharmacodynamics, and Safety of a Single Escalating Dose and Repeated Doses of Rasagiline Transdermal Patch in Healthy Chinese Subjects
被引:1
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作者:
Wang, Meng
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机构:
Soochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R ChinaSoochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R China
Wang, Meng
[1
]
Zhou, Wenjia
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Soochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R ChinaSoochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R China
Zhou, Wenjia
[1
]
Zhang, Quanying
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Soochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R ChinaSoochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R China
Zhang, Quanying
[1
]
Zong, Shunlin
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Soochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R ChinaSoochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R China
Zong, Shunlin
[1
]
Lv, Chengzhe
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机构:
Soochow Univ, Dept Pharmaceut, Childrens Hosp, Suzhou City, Jiangsu, Peoples R ChinaSoochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R China
Lv, Chengzhe
[2
]
机构:
[1] Soochow Univ, Clin Pharmacol Lab, Affiliated Hosp 2, Suzhou City, Jiangsu, Peoples R China
[2] Soochow Univ, Dept Pharmaceut, Childrens Hosp, Suzhou City, Jiangsu, Peoples R China
来源:
CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT
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2020年
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9卷
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05期
A rasagiline transdermal patch can be used to offer continuous rasagiline to patients with Parkinson's disease who cannot take their usual oral medications. This was the first study to investigate the pharmacokinetics, pharmacodynamics, and safety of the rasagiline transdermal patch in healthy Chinese subjects. Thirty subjects were randomized to 3 groups with 10 subjects in each group. The 10 subjects of group 1 received a single 1-mg dose of rasagiline as a tablet; the 20 subjects of groups 2 and 3 received a single transdermal patch (48-hour patch-on period) containing 1.25 mg and 2.5 mg rasagiline, respectively. After a 2-week washout period, the subjects of group 1 were assigned to receive 1 mg of rasagiline tablets every 24 hours for 7 days, and the subjects of group 2 were assigned to receive 1.25-mg rasagiline transdermal patches (48-hour patch-on period) every 72 hours for 5 time periods. The absorption of rasagiline from the transdermal patch was significantly improved, although the peak plasma concentration was obviously reduced. There was slight accumulation of rasagiline dose after multiple administrations. Inhibition of platelet monoamine oxidase-B (MAO-B) activity was dose dependent. The 80% inhibition maintained for at least 48 hours after multiple-dose administration of 1 mg tablets, and for 72 hours after multiple-dose administration of 1.25 mg/48 h patch. Compared with rasagiline tablets, the transdermal patch had a prolonged duration of 80% inhibition and increased maximal inhibition of MAO-B activity. These characteristics permitted an interval of 3 days of dosing, which was convenient for patients to use.
机构:
Capital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
China Natl Clin Res Ctr Neurol Dis, Dept Neurol, Beijing, Peoples R China
Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R ChinaCapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Li, Shuya
Wangqin, Runqi
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Duke Univ, Dept Neurol, Med Ctr, Durham, NC USACapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Wangqin, Runqi
Meng, Xia
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China Natl Clin Res Ctr Neurol Dis, Dept Neurol, Beijing, Peoples R China
Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R ChinaCapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Meng, Xia
Li, Hao
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China Natl Clin Res Ctr Neurol Dis, Dept Neurol, Beijing, Peoples R ChinaCapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Li, Hao
Wang, Yi
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Beijing Inst Lifeom, Natl Ctr Prot Sci Beijing, Beijing Proteome Res Ctr, State Key Lab Prote, Beijing, Peoples R ChinaCapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Wang, Yi
Wang, Haichen
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Duke Univ, Dept Neurol, Med Ctr, Durham, NC USACapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Wang, Haichen
Laskowitz, Daniel
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Duke Univ, Dept Neurol, Med Ctr, Durham, NC USACapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Laskowitz, Daniel
Chen, Xia
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机构:
Capital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
China Natl Clin Res Ctr Neurol Dis, Dept Neurol, Beijing, Peoples R ChinaCapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
Chen, Xia
Wang, Yongjun
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Capital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
China Natl Clin Res Ctr Neurol Dis, Dept Neurol, Beijing, Peoples R China
Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R ChinaCapital Med Univ, BeijingTiantan Hosp, Clin Trial Ctr, Beijing, Peoples R China
机构:
Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Li, Yue-Qi
Yan, Zheng-Yu
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China Pharmaceut Univ, Dept Analyt Chem, Nanjing 210009, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Yan, Zheng-Yu
Zhang, Hong-Wen
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Zhang, Hong-Wen
Sun, Lu-Ning
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Sun, Lu-Ning
Jiao, Hui-Wen
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
China Pharmaceut Univ, Dept Analyt Chem, Nanjing 210009, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Jiao, Hui-Wen
Wang, Mei-Feng
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Nanjing Med Univ, Dept Gastroenterol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Wang, Mei-Feng
Yu, Li-Yuan
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Yu, Li-Yuan
Yu, Lei
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Yu, Lei
Yuan, Zi-Qing-Yun
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Yuan, Zi-Qing-Yun
Meng, Ling
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Meng, Ling
Wang, Yong-Qing
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Nanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
Jiangsu Shengze Hosp, Dept Pharm, Suzhou 215228, Peoples R ChinaNanjing Med Univ, Res Div Clin Pharmacol, Affiliated Hosp 1, Nanjing 210029, Jiangsu, Peoples R China
机构:
Peking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R ChinaPeking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R China
Wang, Hongyun
Ou, Ning
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Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R ChinaPeking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R China
Ou, Ning
Lang, Liwei
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Peking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R ChinaPeking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R China
Lang, Liwei
Shi, Ruihua
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Jiangsu Prov Hosp, Nanjing, Jiangsu, Peoples R ChinaPeking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R China
Shi, Ruihua
Hu, Pei
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Peking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R ChinaPeking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R China
Hu, Pei
Jiang, Ji
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Peking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R ChinaPeking Union Med Coll Hosp, Clin Pharmacol Res Ctr, Beijing 100730, Peoples R China
机构:
Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Kuang, Yun
Wang, Sai-Ying
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Cent South Univ, Dept Anesthesiol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Wang, Sai-Ying
Wang, Meng-Na
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Wang, Meng-Na
Yang, Guo-Ping
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Cent South Univ, Res Ctr Drug Clin Evaluat, Changsha, Peoples R China
Cent South Univ, Dept Pharm, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Yang, Guo-Ping
Guo, Can
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Guo, Can
Yang, Shuang
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Yang, Shuang
Zhang, Xing-Fei
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Zhang, Xing-Fei
Yang, Xiao-Yan
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Yang, Xiao-Yan
Pei, Qi
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Cent South Univ, Dept Pharm, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Pei, Qi
Zou, Chan
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Cent South Univ, Res Ctr Drug Clin Evaluat, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Zou, Chan
He, Yan-Hong
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Cent South Univ, Dept Anesthesiol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
He, Yan-Hong
Zhou, Ying-Yong
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Cent South Univ, Dept Anesthesiol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Zhou, Ying-Yong
Duan, Kai-Ming
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Cent South Univ, Dept Anesthesiol, Xiangya Hosp 3, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Duan, Kai-Ming
Huang, Jie
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Cent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China
Cent South Univ, Res Ctr Drug Clin Evaluat, Changsha, Peoples R ChinaCent South Univ, Ctr Clin Pharmacol, Xiangya Hosp 3, Changsha, Peoples R China