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Bioequivalence ( bioequivalence , BE ) , is a method with a bioavailability study , the pharmacokinetic parameters as indicators , the comparison with the same or different dosage forms of a drug , under the same test conditions , the extent and rate of absorption of active ingredients or without statistical difference human trials . For judging whether the R \u0026 D products listed reference. Bioequivalence trial design commonly used crossover , randomized , parallel-group test methods, the equivalent statistical inference method compared with analysis of variance , two one-sided t-test and confidence interval method . This study for Xiaotangling dispersible tablets bioequivalence testing . 20 healthy volunteers self-controlled , randomized, crossover method , respectively oral Xiaotangling in dispersible tablets (including glibenclamide ) or control drug glibenclamide tablets , different times of the plasma concentration was measured using LC - MS - MS method , BAPP2.0 software to calculate the pharmacokinetic parameters . The results showed that : two formulations grid Glibenclamide Tablets and Xiaotangling dispersible tablets glyburide , its elimination half-life t 1/ 2 < / sub > Ka were 6.6 1.8h and 6.2 ± 1.6h , two the drug peak time ( T max < / sub > ) measured values were 3.3 ± 0.9h and 3.8 ± 1.0H , peak concentration ( C , max < / sub > ) measured value to 97.30 ± 20.99ng · mL -1 and 84.09 ± 21.90ng mL -1 < / sup > . Conclusion: The pharmacokinetic properties of the two formulations .
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