[Translation] A single-center, randomized, open-label, single-dose (fasting/fed) oral bioequivalence study of arginine ibuprofen granules in healthy Chinese subjects: a two-formulation, two-sequence, two-period, crossover study
主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂精氨酸布洛芬颗粒(规格:0.4g(以布洛芬计);生产企业:郑州韩都药业集团有限公司)和参比制剂精氨酸布洛芬颗粒(商品名:司百得®;规格:0.4g(以布洛芬计);生产企业和持证商:海南赞邦制药有限公司)后的药代动力学特征,评价空腹/餐后状态下两种制剂在健康受试者体内的生物等效性。
次要目的:观察受试制剂精氨酸布洛芬颗粒和参比制剂精氨酸布洛芬颗粒(司百得®)在中国健康受试者中的安全性。
[Translation] The primary objective was to investigate the pharmacokinetic characteristics of the test formulation, arginine ibuprofen granules (strength: 0.4 g (ibuprofen); manufacturer: Zhengzhou Handu Pharmaceutical Group Co., Ltd.) and the reference formulation, arginine ibuprofen granules (trade name: SPECTREX®; strength: 0.4 g (ibuprofen); manufacturer and licensee: Hainan Zanbang Pharmaceutical Co., Ltd.), in healthy Chinese volunteers under fasting and fed conditions, and to evaluate the bioequivalence of the two formulations in healthy subjects under fasting and fed conditions.
The secondary objective was to investigate the safety of the test formulation, arginine ibuprofen granules, and the reference formulation, arginine ibuprofen granules (SPECTREX®), in healthy Chinese volunteers.