[Translation] A formal study of bioequivalence of allopurinol extended-release capsules in healthy subjects in a randomized, open-label, two-dose, single-dose, two-sequence, four-period, complete repeat crossover fasting and fed state
主要研究目的:研究空腹/餐后状态下单次口服受试制剂别嘌醇缓释胶囊(规格:250mg,湖北广辰药业有限公司)与参比制剂别嘌醇缓释胶囊(Gichtex®,规格:250mg;G.L. Pharma GmRH持证)在人体内的药代动力学,评价空腹/餐后状态口服两种制剂的生物等效性。 次要研究目的:评价中国健康受试者空腹/餐后单次口服受试制剂别嘌醇缓释胶囊和参比制剂别嘌醇缓释胶囊(Gichtex®)后的安全性。
[Translation] The main purpose of the study: To study the single oral administration of the test preparation Allopurinol Sustained Release Capsules (Specification: 250mg, Hubei Guangchen Pharmaceutical Co., Ltd.) and the reference preparation Allopurinol Sustained Release Capsules (Gichtex®, Specification: 250mg; G.L. Pharma GmRH certificate) Pharmacokinetics in the human body, evaluate the bioequivalence of the two preparations orally in the fasting/fed state. Secondary research purpose: To evaluate the safety of Chinese healthy volunteers after a single oral administration of the test preparation Allopurinol Sustained Release Capsules and the reference preparation Allopurinol Sustained Release Capsules (Gichtex®).