[Translation] Randomized, open-label, single-dose, two-dose, two-sequence, four-cycle, fully repeated crossover bioequivalence study of allopurinol sustained-release capsules (0.25g) in Chinese healthy subjects under fasting and fed administration conditions
主要研究目的:按有关生物等效性试验的规定,选择G.L.Pharma GmbH为持证商的别嘌醇缓释胶囊(商品名:Gichtex®,规格:250mg)为参比制剂,对黑龙江澳利达奈德制药有限公司生产的受试制剂别嘌醇缓释胶囊(商品名:奥迈必利,规格:0.25g )进行空腹和餐后给药人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂别嘌醇缓释胶囊(商品名:奥迈必利,规格:0.25g)和参比制剂别嘌醇缓释胶囊(商品名:Gichtex®,规格:250mg)的安全性。
[Translation] The main purpose of the study: According to the relevant bioequivalence test regulations, select allopurinol sustained-release capsules (trade name: Gichtex®, specification: 250mg) from G.L.Pharma GmbH as the licensed manufacturer as the reference preparation, and test the effect on Heilongjiang Aolida The test preparation Allopurinol Sustained-release Capsules (trade name: Omepride, specification: 0.25g) produced by Ned Pharmaceuticals Co., Ltd. was administered to humans on an empty stomach and after meals for bioequivalence tests to compare the drugs in the test preparation. Whether the difference between the absorption speed and absorption degree of the drug and the reference preparation is within an acceptable range, and evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary research purposes: To observe the oral administration of the test preparation Allopurinol Sustained-release Capsules (trade name: Omepride, specification: 0.25g) and the reference preparation Allopurinol Sustained-release Capsules (trade name: Gichtex®) in healthy subjects. , specification: 250mg) safety.