Bioequivalence and pharmacokinetic characteristics of lovastatin sustained release tablets in Beagle dogs

AIM: To study the oral correlative bioequivalence and pharmacokinetics of lovastatin sustained release tablets in Beagle dogs. METHODS: Twelve Beagle dogs were randomized divided into two groups:A, subjects administered with a single 60 mg oral dose of lovastatin sustained-release tablets and B, lovastatin generic tablets. Plasma lovastatin levels were determined by a reversed-phase HPLC method. The pharmacokinetic parameters were calculated by 3P97 software. RESULTS:The comparison of pharmacokinetic parameters between the two preparations (lovastatin sustained-release tablets, lovastatin generic tablets) were as follow,tmax,cmax,t1/2 and AUC0-(?) were(2.7 ± s 0.8) h,(137 ± 43) μg·L-1,(11 ± 4) h,and (956 ± 146) μg·h·L-1 for lovastatin sustained-release tablets (group A) vs (2.8 ± 1.0) h,(176 ± 59) μg·L-1, (10 ± 5) h ,and (1 005 ± 147) μg·h·L-1 respectively for lovastatin generic tablets(group B). Relative bioavailability of the former was (95 ± 6) %.The 90 % confidence interval calculated from log-transformed values was 81.6 %-112.2 % for logarithm ratio of AUC0-(?) in two groups. CONCLUSION: Lovastatin sustained-release tablets shows prolonged-action characteristics and possesses bioequivalence with lovastatin generic tablets.