AIM: To evaluate the bioequivalence of
lomerizine tablets and
capsules. METHODS: A total of 20 healthy male volunteers were divided randomly into two groups,administering with two
preparations of lomerizine respectively in an open randomized two cross-over test. A single oral dose of the test and reference preparation was 40 mg for each alternatively. Lomerizine concentrations in the serum were determind by high perfermance liquid
chromatography, and the pharmacokinetic
parameters of lomerizine were
obtained by using BECS software. RESULTS: Lomerizine parameters of the tablets and the reference preparation were obtained, t_(max):(2.7±s0.3) h vs(2.6± 0.3) h; c_(max): (93± 11) μg·L~(-1) vs (90±11)μg·L~(-1),
AUC. (435±71)μg·h·L~(-1) vs (432± 77) μg·h·L~(-1)The results of statistical analysis showed that there was no significant differences between c_(max),AUC_(0-t), and t_(max) of the two preparations.The relative bioavailability of lomerizine tablets was (101±12) %. CONCLUSION: The lomerizine tablets and capsules were bioequivalent.
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