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Study on the Relative Bioavailability of Domestic Ciclosporin Soft Capsules / 中国药房
China Pharmacy ; (12)1991.
Artigo em Chinês | WPRIM | ID: wpr-519194
ABSTRACT

OBJECTIVE:

To compare the relative bioavailability and pharmacokinetic parameters of domestic ciclosporin soft capsules with those of imported ciclosporin soft capsules

METHODS:

The drug concentration in blood were assayed by TDx after administration of a single oral dose of 300mg domestic or imported ciclosporin soft capsules to each of 12 healthy male volunteers in a randomized crossover study

RESULTS:

The AUC were(10 47?1 74)?g/(ml?h)and(10 71?1 45)?g/(ml?h),the Cmax were(1 91?0 31)?g/ml and(1 88?0 22)?g/ml,Tmax were(1 46?0 26)h and (1 38?0 31)h,for domestic and imported soft capsules,respectively The relative bioavailability of domestic ciclosporin soft capsules to imported ones was (97 59?9 71)%

CONCLUSION:

The result showed that the two soft capsules were bioequivalent

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Ensaio Clínico Controlado Idioma: Chinês Revista: China Pharmacy Ano de publicação: 1991 Tipo de documento: Artigo

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Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Ensaio Clínico Controlado Idioma: Chinês Revista: China Pharmacy Ano de publicação: 1991 Tipo de documento: Artigo