[Translation] A human bioequivalence study of diclofenac sodium enteric-coated capsules in healthy male volunteers with fasting and postprandial administration, 2 preparations, 4 cycles, 4 sequences, and randomized crossover
健康受试者空腹、餐后口服单剂量双氯芬酸钠肠溶胶囊(受试制剂)与双氯芬酸钠肠溶片(商品名:扶他林,后,测定血浆中双氯芬酸的浓度,研究受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性,并比较饮食对受试制剂和参比制剂药代动力学的影响。
[Translation] Healthy subjects were given a single dose of diclofenac sodium enteric-coated capsules (test preparation) and diclofenac sodium enteric-coated tablets (trade name: Voltaren) on an empty stomach or after a meal. The concentration of diclofenac in plasma was determined to study the absorption rate and extent of the test preparation and the reference preparation, to evaluate whether the test preparation and the reference preparation were bioequivalent, and to compare the effect of diet on the pharmacokinetics of the test preparation and the reference preparation.