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目的评价米格列奈片在健康人体内的生物等效性。方法 24名健康成年男性志愿者采用随机分组自身交叉对照试验设计,单剂量口服10 mg米格列奈片后,用LC-MS/MS法测定血浆中药物浓度。结果米格列奈片和米格列奈钙片的主要药动学参数:t1/2(1.69±0.16)和(1.65±0.28)h;tmax[0.25(0.17~0.5)]和[0.33(0.25~1.50)]h;ρmax(1 165.1±357.50)和(1 081.0±338.41)μg·L~(-1);AUC_(0→τ)(1 489.6±336.85)和(1 378.3±309.56)μg·h·L~(-1);AUC0→∞(1 497.2±339.73)和(1 386.1±311.58)μg·h·L~(-1);AUC_(0→12h)/AUC_(0→∞)(99.51±0.16)%和(99.44±0.24)%;以AUC_(0→12h)计算受试制剂的相对生物利用度为(108.6±10.9)%。结论 2种米格列奈制剂生物等效。
Objective To evaluate the bioequivalence of mitoxanadile tablets in healthy volunteers. Methods Twenty-four healthy adult male volunteers were randomized to receive a crossover self-administered controlled trial. After a single oral dose of 10 mg of mitochondrial tablet was administered, plasma concentrations of the drug were measured by LC-MS / MS. Results The main pharmacokinetic parameters of mitiglinide and mitiglinide were t1 / 2 (1.69 ± 0.16) and (1.65 ± 0.28) h; tmax [0.25 (0.17-0.5)] and [0.33 ~ 1.50)] h; ρmax (1 165.1 ± 357.50) and (1 081.0 ± 338.41) μg · L -1; AUC 0 0 → τ (1 489.6 ± 336.85) and (1 378.3 ± 309.56) μg · h · L -1; AUC 0 → ∞ (1 497.2 ± 339.73) and (1 386.1 ± 311.58) μg · h · L -1; AUC 0-12h / AUC 0-0 ∞ 99.51 ± 0.16)% and (99.44 ± 0.24)% respectively. The relative bioavailability of the test preparation was (108.6 ± 10.9)% calculated by AUC_ (0 → 12 h). Conclusions The two formulations of mitiglinide are bioequivalent.