[Translation] Randomized, open-label, single-dose, two-sequence, two-cycle, double-crossover bioequivalence trial of glipizide dispersible tablets (5 mg) under fasting and postprandial conditions in healthy Chinese subjects
主要研究目的:按有关生物等效性试验的规定,选择Pfizer Italia s.r.l.为持证商的格列吡嗪片(商品名:Minidiab®;规格:5mg)为参比制剂,对山东华素制药有限公司生产并提供的受试制剂格列吡嗪分散片(规格:5mg)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:观察中国健康受试者口服受试制剂格列吡嗪分散片(规格:5mg)和参比制剂格列吡嗪片(商品名:Minidiab®;规格:5mg)后的安全性。
[Translation] Main research purpose: According to the relevant bioequivalence test regulations, select glipizide tablets (trade name: Minidiab®; specification: 5mg) with Pfizer Italia s.r.l. The test preparation glipizide dispersible tablet (specification: 5mg) produced and provided by the company was subjected to fasting and postprandial administration to human body bioequivalence test to compare the absorption rate and extent of the drug in the test preparation and the reference preparation. Whether the difference is within an acceptable range, the bioequivalence of the two formulations under fasting and postprandial dosing conditions was evaluated.
Secondary research objective: To observe the safety of Chinese healthy subjects after oral administration of test preparation glipizide dispersible tablets (specification: 5mg) and reference preparation glipizide tablets (trade name: Minidiab®; strength: 5mg) .