ThebioequivalencestudyoffluoxetineHClcapsu.docVIP

The bioequivalence study of fluoxetine HCl capsule and its dispersible tablets in healthy volunteers SHAO Qingxiang1 ,Li Chuan2 ,ZHANG Meiyun1 ,Ji Zhou2hua2 ,LIU Ping3 , WEI Yang1 ,XU Fang2 ,DU Fei2fei2 ,CUI Jian3 ,HUANG Bin3 3 Eli L illy Asia , S hanghai 200001 , China ) ( 1 Zhejiang A cadem y of Medical Sciences , Hangzhou 310013 , China ; 2 S hanghai I nstit ute of M ateria Medica , Chinese A cadem y of Sciences , S hanghai 200031 , China ; persible tablet s. Methods :In t he study , [ Abstract] 　 Objective :To evaluate t he bioequivalence between fluoxetine HCl capsule and it22 healt hy male volunteers were randomized to receive a single oral dose of 20mg fluoxetine HCl capsule or it s dispersible tablet s using cross2over design. Blood samples were taken according to design and t he bioequivalence was evaluated by use of plasma concent rations of HCl dispersible tablet s and it s capsule were expressed respectively as following : Cmax was40) and ( 17. 02 ± 73) ng ml- 1 ; T max was ( 6. 8 ± 7) and ( 6. 1 ± 2) h ;AUC0～ ∞ was ( 971. 08 ± 4. mL 1. 1. of fluoxetine HCl metabolit ( norfluoxzetine) in it s dispersible tablet s and capsule were expressed respec2 ? 1994-2010 ( 16. 96 ± 5. fuoxetine and its metabolite determined by L C/ MS/ UV technique. Results : The data for fluoxetine 541. 48) and ( 1 018. 72 ± 583. 46) ng?? - 1 ; t 1/ 2 was ( 59. 6 ± 9 ) and ( 61. 3 ± 0 ) h. The data h L 18. 20. tively as following : Cmax was ( 20. 05 ± 33) and ( 19. 55 ± 10) ng? - 1 ; T max was ( 74. 6 ± 1) 10. 8. mL 53. and ( 80. 0 ± 4) h ,AUC0～ ∞ was ( 6 171. 86 ± 320. 18) and ( 6 312. 87 ± 025. 06) ng?? - 1 ; t 1/ 2 56. 3 3 h L was ( 155. 6 ± 7) and ( 165. 7 ± 7) h. Conclusion :The fluoxeting HCl capsule and it s dispersible 40. 65. tablet s are of bioequvalence. [Key words] fluoxetine HCl ;dispersible tablet ;capsule ;L C/ MS/ MS ;bioequivalence Hydrochloric acid prozac, namely (plus or minus 2 N 2 232 232 methyl phenyl [(2, 2, and 3 fluorine 2 P2 armour phenyl)