Bioequivalence of imported and domestic risperidone film-coated tablets in healthy volunteers
10.3969/j.issn.1001-6821.2009.04.006
- VernacularTitle:进口与国产利培酮薄膜衣片在健康志愿者的生物等效性
- Author:
Xia ZHAO
1
;
Jing-Li DU
;
Xiao LIU
;
Ying ZHOU
;
Yan LIANG
;
Wei SUN
;
Yi-Min CUI
Author Information
1. 北京大学第一医院
- Keywords:
risperidone film-coated tablets;
pharmacokinetics;
bioequivalence;
HPLC-MS/MS
- From:
The Chinese Journal of Clinical Pharmacology
2009;25(4):312-315
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the pharmacokinetics and bioequiva-lence of risperidone film-coated tablets in healthy volunteers. Meth-ods A single administration of 2 mg risperidone of test and reference formulation was given to 23 healthy male volunteers according to an open, randomized, cross-over design. The concentration of risperi-done and 9-hydrorisperidone were determined by HPLC - MS/MS.The main pharmacokinetics were calculated and bioequivalence of two formulations were evaluated. Results The main pharmacokinetic pa-rameters of test and reference formulation were as follows, rispcridone:AUC0-twere(94.76±82.93 ) and( 103.05 ± 117.71 )ng · h · mL-1,AUC0～1 were ( 96.72 ± 84.52 ) and ( 105.19 ± 119.36 )ng·h·mL-1,Cmax were (15.91±5.63) and(16.21 ± 11.56)ng·mL-1, tmaxwere (1.14±0. 73) and(1.15 ± 0.54)h, t1/2 were (7.32±5.94) and (7.44 ± 6.50 ) h, respectively. The relative bioavailability of risperi-done was ( 106.68 ± 40.21 ) % ; 9 - hydrorisperidone: AUC0～96hwere(268.56±85.20) and(279.64 ± 117.86) ng·h·mL-1, AUC0-∞were (282.74 ± 87.46 ) and (294.28 ± 120.32 ) ng · h · mL-1, Cmax were ( 10.84 ± 4.69 ) and ( 11.11 ± 4.80 ) ng·mL-1, tmaxwere (3.35 ± 2.32) and(4.48 ± 2.76) h, t1/2 were (23.18 ± 3.26) and ( 23.12 ± 4.31 ) h, respec-tively. The relative bioavailability of 9 - hydrorisperidone was( 101.37 ± 27.23 ) %. Conclusion The two formula-tions were bioequivalent.
