乙酰半胱氨酸泡腾片在健康受试者中随机、开放、两制剂、单剂量、两序列、两周期、自身交叉的空腹和餐后状态下的生物等效性正式试验
[Translation] A randomized, open-label, two-formulation, single-dose, two-sequence, two-period, self-crossover formal bioequivalence study of acetylcysteine effervescent tablets in healthy subjects under fasting and fed conditions
研究空腹/餐后状态下单次口服受试制剂乙酰半胱氨酸泡腾片(规格:0.6 g,浙江领创优品药业有限公司)与参比制剂乙酰半胱氨酸泡腾片(商品名:富露施®,规格:0.6 g;Zambon S.p.A.)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。
[Translation] The pharmacokinetics of the test preparation acetylcysteine effervescent tablets (specification: 0.6 g, Zhejiang Lingchuang Youpin Pharmaceutical Co., Ltd.) and the reference preparation acetylcysteine effervescent tablets (trade name: Fulucis®, specification: 0.6 g; Zambon S.p.A.) in humans after a single oral dose in the fasting/fed state were studied, and the bioequivalence of the two preparations in the fasting/fed state was evaluated.
中国健康男性受试者空腹和餐后单次口服他达拉非片的随机、开放、两序列、两周期、双交叉设计的生物等效性试验
[Translation] A randomized, open-label, two-sequence, two-period, double-crossover bioequivalence study of a single oral dose of tadalafil tablets in Chinese healthy male volunteers after fasting or after meals
1. 研究空腹单次口服他达拉非片受试制剂(20mg,浙江领创优品药业有限公司)与他达拉非片参比制剂(20mg,持证商:Eli Lilly Nederland B.V.)后他达拉非在中国健康男性受试者体内的药代动力学行为,评价空腹口服两种制剂的人体生物等效性。
2. 研究餐后单次口服他达拉非片受试制剂(20mg,浙江领创优品药业有限公司)与他达拉非片参比制剂(20mg,持证商:Eli Lilly Nederland B.V.)后他达拉非在中国健康男性受试者体内的药代动力学行为,评价餐后口服两种制剂的人体生物等效性。
次要目的:评价中国健康男性受试者空腹和餐后单次口服他达拉非片受试制剂和参比制剂后的安全性。
[Translation] 1. To study the pharmacokinetic behavior of tadalafil in healthy Chinese male subjects after a single oral administration of the test formulation of tadalafil tablets (20 mg, Zhejiang Lingchuang Youpin Pharmaceutical Co., Ltd.) and the reference formulation of tadalafil tablets (20 mg, licensee: Eli Lilly Nederland B.V.) on an empty stomach, and to evaluate the human bioequivalence of the two formulations after oral administration on an empty stomach.
2. To study the pharmacokinetic behavior of tadalafil in healthy Chinese male subjects after a single oral administration of the test formulation of tadalafil tablets (20 mg, Zhejiang Lingchuang Youpin Pharmaceutical Co., Ltd.) and the reference formulation of tadalafil tablets (20 mg, licensee: Eli Lilly Nederland B.V.) after a meal, and to evaluate the human bioequivalence of the two formulations after oral administration on a empty stomach.
Secondary objective: To evaluate the safety of the test formulation and reference formulation of tadalafil tablets in healthy Chinese male subjects after a single oral administration of tadalafil tablets on an empty stomach and after a meal.
100 Clinical Results associated with Zhejiang Lingchuang Youpin Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhejiang Lingchuang Youpin Pharmaceutical Co., Ltd.
100 Deals associated with Zhejiang Lingchuang Youpin Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang Lingchuang Youpin Pharmaceutical Co., Ltd.