Bioequivalence of Domestic Meloxicam Tablets in Healthy Volunteers / 中国药房
China Pharmacy
; (12)2001.
Artigo
em Chinês
| WPRIM (Pacífico Ocidental)
| ID: wpr-518411
Biblioteca responsável:
WPRO
ABSTRACT
OBJECTIVE:
The bioequivalence and pharmacokinetics of two kinds of domestic meloxicam tablets were studied in 20 healthy male volunteersMETHODS:
A dose of 15mg of domestic or imported meloxicam(test and reference preparation)was given according to arandomized 2-way cross-over design,blood samples were withdrawn up to 96 hours post administration,and plasma concentration of meloxicam was determined by high performance liquid chromatography(HPLC)methodRESULTS:
The peak plasma levels(Cmax)of meloxicam test drug and reference drug were (2 736 2?312 0)and(2 665 6?333 8)?g/L,respectively,the peak time(Tmax)were(4 25?1 16)h and(4 00?1 30)h,respectively,T1/2ke were(21 67?3 81)h and(21 05?3 30)h,respectively,and AUC0~t were(96 454 6?25 526 6)and(95 692 5?24 532 6)?g/(h?L),respectively There were no significant differences in AUC0~t,Tmax,Cmax and T1/2ke between two kinds of tabletCONCLUSION:
The relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic meloxicam tablets and imported meloxicam tablets The relative bioavailablility of the test drug was(101 3?11 9)%
Texto completo:
Disponível
Base de dados:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Ensaio clínico controlado
Idioma:
Chinês
Revista:
China Pharmacy
Ano de publicação:
2001
Tipo de documento:
Artigo