Aarbakke J, Gadeholt G, Høylandskjaer A
Int J Clin Pharmacol Ther Toxicol. 1983 Jun;21(6):281-3.
The pharmacokinetics of two naproxen tablet formulations were compared after oral administration. The 250-mg naproxen tablets, tablet I from AFI, Oslo, Norway, and tablet II Naprosyn, Astra-Syntex, were taken by 12 healthy volunteers in a randomized two-period crossover study. Plasma levels of naproxen were measured by a sensitive and specific HPLC method. The data were analyzed by means of two-way analysis of variance to test for significant differences between tablet formulation and differences between the first and second trial periods. Rapid absorption, with most Cmax values from 50-60 micrograms/ml reached within 1.5-3 h, was found for both tablet formulations. No significant difference was found in the rate and extent of absorption between the two formulations: the relative bioavailability of tablet I compared to tablet II was 1.05 +/- 0.21 (mean +/- SD). The naproxen concentration 2 h after ingestion and the Cmax were higher on the second occasion, regardless of preparation, suggesting that the subjects were clinically different on the two occasions.
口服给药后比较了两种萘普生片剂制剂的药代动力学。在一项随机双周期交叉研究中，12名健康志愿者服用了250毫克萘普生片剂，即来自挪威奥斯陆AFI的片剂I和阿斯特拉-辛泰克斯的萘普生片剂II。采用灵敏且特异的高效液相色谱法测定血浆中萘普生的水平。通过双向方差分析对数据进行分析，以检验片剂制剂之间的显著差异以及第一和第二试验期之间的差异。两种片剂制剂均呈现快速吸收，大多数Cmax值在1.5至3小时内达到50 - 60微克/毫升。两种制剂在吸收速率和程度上未发现显著差异：片剂I相对于片剂II的相对生物利用度为1.05±0.21（平均值±标准差）。无论制剂如何，第二次服用后2小时的萘普生浓度和Cmax均较高，这表明受试者在两次服用时临床上存在差异。
