Study on the Pharmacokinetics and Bioequivalence of Mycophenolate Mofetil Soft Capsules
- VernacularTitle:吗替麦考酚酯软胶囊的药动学及生物等效性研究
- Author:
Jungang DENG
;
Lidong DENG
- Publication Type:Journal Article
- Keywords:
Mycophenolate mofetil soft capsules;
Naproxen;
Pharmacokinetics;
Bioequivalence;
HPLC
- From:
China Pharmacy
2005;0(24):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the relative bioavailability and pharmacokinetics of Mycophenolate mofetil capsules vs.Mycophenolate mofetil soft capsules in healthy volunteers.METHODS:In double period randomized crossover study,20 healthy volunteers were given a single oral dose of trial capsule and reference capsule 4 pills(0.25 g per pill).The concentration of mycophenolate(MPA) was determined by HPLC.Pharmacokinetic parameters were calculated using DAs 2.0 software and the bioequivalence of 2 formulations were evaluated.RESULTS:Main pharmacokinetic parameters of trial capsule vs.reference capsule were as follows:AUC0→t:(69.95?14.13)?g?h?mL-1 vs.(66.95?19.05)?g?h?mL-1;AUC0→∞:(85.18?20.51)?g?h?mL-1 vs.(77.39?23.78) ?g?h?mL-1;Cmax:(31.26?13.09)?g?mL-1 vs.(31.90?14.45)?g?mL-1;tmax:(0.875?0.358)h vs.(0.775?0.291)h.The relative bioavailability of Mycophenolate mofetil soft capsules in 20 healthy volunteers was(109.6?26.9)%.CONCLUSION:Results of study indicated the 2 formulations are bioequivalent.
