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目的:通过交叉试验比较两种萘普生钠制剂的生物等效性。方法:以8名男性志愿受试者按交叉试验方案以高效液相色谱法测定血浓度。进行两种制剂一次口服给药300mg的药物动力学和生物利用度比较试验。结果:两种片剂药物动力学参数无显著差异。试验片的相对生物利用度为112.2%。结论:在8名受试者交叉试验证明两种制剂萘普生钠片生物利用度相当,证明两种片剂生物等效。
OBJECTIVE: To compare the bioequivalence of two naproxen sodium preparations by cross-over test. Methods: Eight male volunteers were tested for blood concentration by high performance liquid chromatography in a crossover protocol. Pharmacokinetic and bioavailability comparative trials of 300 mg of the two formulations were orally administered once. RESULTS: There was no significant difference in pharmacokinetic parameters between the two tablets. The relative bioavailability of the test piece was 112.2%. CONCLUSIONS: Cross-over trials in eight subjects demonstrated comparable bioavailability of naproxen sodium tablets for both formulations, demonstrating that both tablets are bioequivalent.