Pharmacokinetics and bioequivalence of dexlansoprazole delayed release capsules in Beagle dogs
Abstract
Objective To study the pharmacokinetics profile of dexlansoprazole delayed release capsules in beagle dogs.Methods Ten Beagle dogs were administered with an oral single and multiple doses of test and reference capsules of dexlansoprazole in a randomized two-way cross-over test and the plasma concentrations of dexlansoprazole were determined by LC-MS/MS method.The pharmacokinetic parameters were calculated by Win Nolin 6.1 software.Results The main pharmacokinetic parameters of dexlansoprazole test and reference capsules after a single dose were as follows: t1 /2=(1.2 ± 1.0) and(1.0 ± 0.7) h; tmax=(2.3 ± 1.0)and(2.6 ± 1.1) h; ρmax=(2.388 6 ± 0.639 1) and(2.348 5 ± 0.728 6)mg·L-1; AUC0-t=(5.601 4 ±1.627 4) and(5.602 3 ± 1.865 7)mg·h·L-1; AUC0-∞=(5.653 6 ± 1.630 9) and(5.657 5 ± 1.878 6)mg·h·L-1,respectively.The relative bioavailability was(101.6 ± 8.9) %.The main pharmacokinetic parameters after multiple doses were similar to those after a single dose.Conclusions There is a significant individual difference on dexlansoprazole in Beagle dogs.The two kinds of dexlansoprazole delayed release capsules are bioequivalent in Beagle dogs.
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