[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, double-crossover bioequivalence study of paliperidone extended-release tablets in healthy subjects under the fed state
主要试验目的:以合肥华方医药科技有限公司提供的帕利哌酮缓释片(规格:6 mg)为受试制剂,以Janssen Cilag Manufacturing L.L.C.生产的帕利哌酮缓释片(商品名:芮达®,规格:6 mg)为参比制剂,按生物等效性试验的相关规定,比较在中国健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
次要试验目的:评价中国健康受试者单次餐后口服受试制剂和参比制剂后的安全性。
[Translation] The main purpose of the study was to use the paliperidone extended-release tablets (specification: 6 mg) provided by Hefei Huafang Pharmaceutical Technology Co., Ltd. as the test preparation and the paliperidone extended-release tablets (trade name: Ruida®, specification: 6 mg) produced by Janssen Cilag Manufacturing L.L.C. as the reference preparation. According to the relevant provisions of the bioequivalence test, the pharmacokinetic behavior in healthy Chinese subjects was compared to evaluate the bioequivalence of the two preparations.
Secondary purpose of the study was to evaluate the safety of the test preparation and the reference preparation after a single oral administration after a meal in healthy Chinese subjects.