Palazzini E, Cristofori M, Babbini M
Medical Department, Alfa Wassermann S.p.A., Bologna, Italy.
Int J Clin Pharmacol Res. 1992;12(4):179-84.
The influence of concomitant food intake on the plasma concentration of naproxen given as a new controlled-release (CR) formulation (750-mg tablet) was investigated in a crossover study design. Twelve healthy volunteers received a single tablet of naproxen on two occasions separated by a 3-week washout period:- after an overnight fast and immediately after a standard meal. Plasma naproxen levels were measured through HPLC at intervals suitable for obtaining concentration-time curves of both regimens in the range 1--48 hours. It was found that average plasma AUC values were 1978.7 mcg.hr/ml in fasting participants and 1778.6 mcg.hr/ml in postprandial participants. The confidence interval computed by Westlake's method indicated equivalence of values. Food decreased the peak plasma concentration of CR naproxen by about 14%, but the confidence interval (+/- 22%) barely exceeded equivalence limits. There were no significant differences between fasting versus postprandial values for the mean absorption time, or plasma absorption and disposition half-lifes. It is concluded that the bioavailability of CR naproxen is not substantially altered by the ingestion of food.
在一项交叉研究设计中，研究了伴随食物摄入对以新的控释（CR）制剂（750毫克片剂）形式给予的萘普生血浆浓度的影响。12名健康志愿者在两个不同时间分别服用一片萘普生，两次服药间隔3周的洗脱期：一次是在过夜禁食后，另一次是在标准餐后立即服用。通过高效液相色谱法（HPLC）在1 - 48小时范围内以适合获得两种给药方案浓度-时间曲线的间隔测量血浆萘普生水平。结果发现，禁食参与者的平均血浆AUC值为1978.7 mcg.hr/ml，餐后参与者为1778.6 mcg.hr/ml。用韦斯特莱克方法计算的置信区间表明数值具有等效性。食物使CR萘普生的血浆峰浓度降低约14%，但置信区间（±22%）勉强超过等效限度。禁食与餐后的平均吸收时间、血浆吸收半衰期和处置半衰期值之间无显著差异。结论是，摄入食物不会实质性改变CR萘普生的生物利用度。
