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目的：２４名健康男性志愿受试者随机交叉单剂量口服国产美洛普康片和进口美洛昔康片１５ｍｇ，研究国产片剂的人体相对生物利用度。方法：采用高效波相色谱法测定血浆中美洛昔康的浓度，并进行药代动力学研究及两制剂生物等效性评价。结果：对所测得的血药浓度－时间数据用３Ｐ９７进行拟合，受试者的药－时曲线符合二室模型。国产美洛昔康片与莫比可的Ｃｍａｘ分别为１．３４±０．３５ｍｇ·Ｌ－１与 １．０３±０．２２ ｍｇ·Ｌ－１， ｔｐｅａｋ分别为 ２。１５±１．５９ｈ与 ５２８±２．１０ｈ， ｔ１／２β分别为３３．９０±２４．５６ｈ与３１．２５±１７．１７ｈ， ＡＵＣ０－ｉｎｆ分别为３９．６７±１０．６４ ｍｇ·ｈ·Ｌ－１与３８．６５±１０．６３ ｍｇ·ｈ·Ｌ－１。以莫比可为参比，国产美洛昔康片的相对生物利用度为（１０４．３± １７．８）％。结论：经方差分析、双单侧 ｔ检验法和［１－２ α］置信区间检验，显示两制剂具有生物等效性。试验中仅见个别病例出现轻微药物不良反应。
OBJECTIVE: Twenty-four healthy male volunteers were randomized to receive a single oral dose of meloplatin and imported meloxicam 15mg to study the relative bioavailability of domestic tablets. Methods: The concentration of meloxicam in plasma was determined by high performance liquid chromatography. The pharmacokinetics and the bioequivalence of the two preparations were evaluated. RESULTS: The measured plasma concentration-time data were fitted with 3P97, and the patient’s drug-time curve was fitted to a two-compartment model. The Cmax values of domestic meloxican tablets and moecoxib were 1.34 ± 0.35 mg · L-1 and 1.03 ± 0.22 mg · L-1, respectively, and the tpeaks were 2.15 ± 1.59 h and 528 ± 2.10h, t1 / 2β were 33.90 ± 24.56h and 31.25 ± 17.17h respectively, AUC0-inf were 39.67 ± 10.64 mg · h · L-1 and 38.65 ± 10.63 mg · h · L-1. The relative bioavailability of domestic meloxicam tablets was (104.3 ± 17.8)%. CONCLUSIONS: ANOVA, two-sided one-tailed t-test and [1-2 α] confidence interval test showed that both formulations were bioequivalent. Only a few cases of trial showed slight adverse drug reactions.