[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study was conducted to evaluate the bioequivalence of the test formulation, paliperidone extended-release tablets (strength: 3 mg), and the reference formulation, Rida (strength: 3 mg), in healthy adult subjects under fasting and fed conditions.
主要研究目的:研究空腹和餐后状态下单次口服受试制剂帕利哌酮缓释片(规格:3 mg,辰欣药业股份有限公司生产)与参比制剂帕利哌酮缓释片(芮达,规格:3 mg,Janssen Cilag Manufacturing L.L.C.生产)在健康受试者体内的药代动力学,评价空腹和餐后状态下口服两种制剂的生物等效性。
次要研究目的:评估受试制剂帕利哌酮缓释片(规格:3 mg)和参比制剂帕利哌酮缓释片(芮达,规格:3 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation paliperidone extended-release tablets (specification: 3 mg, produced by Chenxin Pharmaceutical Co., Ltd.) and the reference preparation paliperidone extended-release tablets (Rida, specification: 3 mg, produced by Janssen Cilag Manufacturing L.L.C.) in healthy subjects after a single oral administration under fasting and fed conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting and fed conditions.
Secondary purpose of the study is to evaluate the safety of the test preparation paliperidone extended-release tablets (specification: 3 mg) and the reference preparation paliperidone extended-release tablets (Rida, specification: 3 mg) in healthy subjects.