[Translation] A preliminary bioequivalence study of aminophylline tablets in Chinese healthy participants under fasting administration conditions, using a randomized, open-label, single-dose, two-formulation, two-sequence, four-period, fully replicated crossover approach.
主要研究目的:按有关生物等效性试验的规定,选择アルフレッサ ファーマ株式会社持证的氨茶碱片(商品名:Neophyllin®,规格:100mg)为参比制剂,对云鹏医药集团有限公司生产并提供的受试制剂氨茶碱片(规格:0.1g(按C2H8N2(C7H8N4O2)2·2H20计))进行空腹给药人体生物等效性预试验,比较两种制剂在中国健康试验参与者体内的药代动力学行为,评估两种制剂在空腹给药条件下生物等效性的可能性,为正式试验设计提供参考依据。
次要研究目的:观察健康试验参与者口服受试制剂氨茶碱片(规格:0.1g(按C2H8N2(C7H8N4O2)2·2H20计))和参比制剂氨茶碱片(商品名:Neophyllin®,规格:100mg)的安全性。
[Translation] Main research objective: In accordance with relevant bioequivalence testing regulations, aminophylline tablets (trade name: Neophyllin®, specification: 100mg) certified by Alfres Farm Co., Ltd. were selected as the reference formulation. A preliminary human bioequivalence study was conducted on the test formulation aminophylline tablets (specification: 0.1g (calculated as C2H8N2(C7H8N4O2)2·2H2O)) manufactured and supplied by Yunpeng Pharmaceutical Group Co., Ltd., under fasting administration. The pharmacokinetic behavior of the two formulations in healthy participants in Chinese trials was compared, and the likelihood of bioequivalence between the two formulations under fasting administration conditions was assessed, providing a reference for the design of the formal trial.
Secondary study objective: To observe the safety of oral administration of the test formulation aminophylline tablets (strength: 0.1g (calculated as C2H8N2(C7H8N4O2)2·2H2O)) and the reference formulation aminophylline tablets (trade name: Neophyllin®, strength: 100mg) in healthy participants.