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Pharmacokinetics and bioequivalence of Nifedipine Sustained-release Pellets in Beagle dogs

XIAO Zhenglin;DING Jinsong;Department of Pharmacy,Xiangtan Central Hospital;College of Pharmaceutical Sciences,Central South University;  
Objective To assess the relative bioavailability and bioequivalence of Nifedipine Sustained-release Pellets in beagle dogs.Methods 6 beagle dogs were orally administrated a single dose of 20 mg of Nifedipine Sustained-release Pellets and Coracen~after randomly divided into 2 groups.The crossover dose was given after 1 week wash-out.The blood samples were determined by an LC-MS/MS method with diazepam as internal standard,and the pharmacokinetic parameters and bioequivalence were studied.Results The main pharmacokinetic parameters of Nifedipine Sustained-release Pellets and Coracen~were as follows:t1/25.03±1.16 and 4.67±1.02 h;tmax3.83±0.41 and 3.67±0.52 h;AUC0-24 h164.99±20.32 and 155.41±23.43 ng·h·mL~(-1);Cmax27.11±2.87 and 28.72±4.88 ng·mL~(-1).Compared with Coracen~,the main pharmacokinetic parameters of Nifedipine Sustained-release Pellets showed no different significantly(P0.05),two one-sided test and(1-2α)confidence intervals demonstrated both formulations were bioequivalence.Conclusion The release and adsorption in vivo of Nifedipine Sustained-release Pellets were similar to Coracen~,and they were bioequivalent.
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