The bioequivalence study of fluoxetine HCl capsule and its dispersible tablets in healthy volunteers
文献类型：期刊论文
| 作者 | Shao Qingxiang1; Li Chuan1; Zhang Meiyun1; Ji Zhouhua2; Liu Ping2; Wei Yang1; Xu Fang1; Du Fweifei1; Cui Jian2; Huang Bin2 |
| 刊名 | Chinese Journal New Drugs
 |
| 出版日期 | 2003 |
| 卷号 | 12期号:4页码:277-281 |
| 关键词 | fluxoetine HCl dispersible tablet LC/MS/MS bioequivalence |
| ISSN号 | 1003-3734 |
| 其他题名 | 盐酸氟西汀分散片和胶囊的生物等效性研究 |
| 文献子类 | Article |
| 英文摘要 | Objective: To evaluate the bioequivalence between fluoxetine HCL capsule and its dispersible tablets. Methods: In the study, 22 healthy male volunteers were randomized to receive a signle oral dose of 20mg fluoxetine HCl capsule or its dispersible tablets using cross-over design. Blood samples were taken according to design and the bioequivalence was evaluated by use of plasma conscentrations of fuoxetine and its metabolite determined by LC/MS/UV technique. Results: The data for fluoxetine HCl dispersible tablets and its capsule were expressed respectively as following: C_(max) was (16．965．40) and (17．024．73)ng·mL~-1; T_(max) was (6．81．7) and (6．11．2)h；AUC0 was (971．08541．48) and (1018．72583．46)ng·h·L~-1；t1/2 was (59．618．9) and (61．320．0)h. The data of fluoxetine HCl metabolit (nrofluoxzetine) in its dispersible tablets and capsule were expressed respectively as following : C_(max) was (20．0510．33) and (19．558．10)ng·mL~-1；Tmax was (74．653．1) and (80．056．4)h；AUC0- was (6171．863320．18) and (6312．873025．06)ng·h·L~-1；t_(1/2) was (155．640．7) and (165．765．7)h. Conclusion: The fluoxeting HCl capsule and its dispersible tablets are of bioequvalence. |
| WOS研究方向 | Pharmacology & Pharmacy (provided by Clarivate Analytics) |
| 语种 | 中文 |
| CSCD记录号 | CSCD:1470104 |
| 源URL | [http://119.78.100.183/handle/2S10ELR8/268434]  |
| 专题 | 中国科学院上海药物研究所 |
| 作者单位 | 1.Zhejiang Academy of Medical Sciences, Hangzhou, Zhejiang 310013, China.; 2.Eli Lilly Asia Inc, Shanghai 200001, China. |
| 推荐引用方式 GB/T 7714 | Shao Qingxiang,Li Chuan,Zhang Meiyun,et al. The bioequivalence study of fluoxetine HCl capsule and its dispersible tablets in healthy volunteers[J]. Chinese Journal New Drugs,2003,12(4):277-281. |
| APA | Shao Qingxiang.,Li Chuan.,Zhang Meiyun.,Ji Zhouhua.,Liu Ping.,...&Huang Bin.(2003).The bioequivalence study of fluoxetine HCl capsule and its dispersible tablets in healthy volunteers.Chinese Journal New Drugs,12(4),277-281. |
| MLA | Shao Qingxiang,et al."The bioequivalence study of fluoxetine HCl capsule and its dispersible tablets in healthy volunteers".Chinese Journal New Drugs 12.4(2003):277-281. |
入库方式： OAI收割
来源：上海药物研究所
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