Pharmacokinetics and bioequivalence of sustained-released tablet of nefopam
- VernacularTitle:盐酸奈福泮缓释片药代动力学及生物等效性
- Author:
Shaohua WANG
;
Baodong YU
;
Anjin CHEN
;
Xiao CHU
;
Xindao JIANG
;
Meiling ZHAO
;
Meixing YAN
;
- Publication Type:Journal Article
- Keywords:
nefopam hydrochloride;
sustained released tablet;
HPLC;
bioequivalence
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2000;0(01):-
- CountryChina
- Language:Chinese
-
Abstract:
AIM: To verify the bioequivalence between sustained released tablet of nepopam and normal one. METHODS: 18 volunteers were randomly devided into two groups. Double periodical crossed design was used, and poly dose of nefopam was administered to 18 volunteers following single dose after one week interval. The concentration of nefopam hydrochloride in serum was determinated by HPLC, and the related parameters came out through 3p97 programme. RESULTS: In the single dose test the drug concentration of sustained released tablet maitained 2040 mg?L -1 for 10 h ,c max was ( 45.8 ?15.7) mg?L -1 ,t peak was ( 3.4 ? 0.8) h , and the corresponding parameters of normal tablet were over 20 mg?L -1 for 7.5 h ,( 72.7 ?26.0) mg?L -1 ,and ( 1.6 ? 0.6) h . The AUC was ( 363.4 ? 107.1 ) and ( 374.8 ?125.7) mg?h?L -1 respectively, and F was ( 1.02 ? 0.25 ). In the poly dose test the c max of sustained released and normal one was ( 31.50 ? 12.65 ) and ( 33.68 ?10.51) mg?L -1 ,c min was ( 13.4 ? 4.4 ) and ( 10.9 ?5.4) mg?L -1 , t peak was ( 2.6 ? 0.6 ) and ( 1.22 ? 0.46) h , and FI was ( 0.77 ? 0.26 ) and ( 1.04 ? 0.18 ) respectively. CONCLUSION: The sustained released tablet is credible and the two types of tablet are equieffective in AUC.
