/ CompletedNot Applicable [Translation] Study on the bioequivalence of nitrofurantoin capsules in healthy volunteers
主要目的:
采用单中心、随机、开放、两周期交叉、单次口服给药试验设计,比较空腹和餐后给药条件下亿药通(河北)生物科技有限公司提供的呋喃妥因胶囊(规格:100 mg)与Almatica Pharma LLC持证的呋喃妥因胶囊(商品名:Macrodantin®;规格:100 mg)在中国健康人群吸收程度和吸收速度的差异。
次要目的:
评价空腹及餐后条件下,亿药通(河北)生物科技有限公司提供的呋喃妥因胶囊(规格:100 mg)与Almatica Pharma LLC持证的呋喃妥因胶囊(商品名:Macrodantin®;规格:100 mg)在健康受试者体内的安全性。
[Translation] Primary objective:
A single-center, randomized, open, two-period crossover, single oral administration trial design was used to compare the differences in the degree and rate of absorption of Nitrofurantoin Capsules (Specification: 100 mg) provided by Yiyaotong (Hebei) Biotechnology Co., Ltd. and Nitrofurantoin Capsules (Trade Name: Macrodantin®; Specification: 100 mg) licensed by Almatica Pharma LLC in healthy Chinese subjects under fasting and fed conditions.
Secondary objective:
Evaluate the safety of Nitrofurantoin Capsules (Specification: 100 mg) provided by Yiyaotong (Hebei) Biotechnology Co., Ltd. and Nitrofurantoin Capsules (Trade Name: Macrodantin®; Specification: 100 mg) licensed by Almatica Pharma LLC in healthy subjects under fasting and fed conditions.
100 Clinical Results associated with Yiyaotong (Hebei) Biotechnology Co., Ltd.
0 Patents (Medical) associated with Yiyaotong (Hebei) Biotechnology Co., Ltd.
100 Deals associated with Yiyaotong (Hebei) Biotechnology Co., Ltd.
100 Translational Medicine associated with Yiyaotong (Hebei) Biotechnology Co., Ltd.