Eliminate Sugar Spirit Dispersible Tablets Bioequivalence Clinical Trials

Bioequivalence is a investigation in human beings . The test compare a chemical preparation in the same or different dosage form , in the same test condition, whether the level and the speed of assimilate of active ingredient have statistical difference, using the mathod of bioavailabilitiy and the index of pharmacokinetic parameter. According to the concision , decision is made to allow a new product on the market. Randomized parallel control design, cross-over design are commonly applied in equivalence trials. The methods for statistical inference are ANOVA, two one-side t tests or confidence intervals. Bioequivalence investigates the PK parameters (such as AUC Cmax and Tmax) of both trial drug and reference drug.Bioequivalence trials of xiaotangling tablets was introduced in this paper. A single dose of two dosage forms, glibenclamide tablets and xiaotangling tablets (containing glibenclamide)was given to 20 healthy volunteers under randomized self_controlled crossovertrial, and plasma concentrations in differen time points were detected. Methods: LC-MS-MS Pharmacokinetic parameters were calculated by BAPP2. 0. The half time of elimination (t_1/2Ka) in glibenclamide tablets and xiaotangling tablets were 6. 6±1. 8h and 6. 2 ±1. 6h. The peak time (T_max) were3. 3±0. 9h and 3. 8± 1. Oh and the peak concentration (C_max) were 97. 30±20. 99ng · mL^-1 and 84. 09±21. 90ng · mL^-1.Concision: The pharmacokinetic characteristics of glibenclamide in two dosage for forms are simila.