醋酸氟氢可的松片在空腹及餐后条件下的人体生物等效性试验
[Translation] Human bioequivalence test of fludrocortisone acetate tablets under fasting and postprandial conditions
主要研究目的:
本研究考察空腹及餐后条件下单次口服由江苏福锌雨医药科技有限公司提供的醋酸氟氢可的松片(受试制剂,规格:0.1mg)或由アスペンジャパン株式会社生产的醋酸氟氢可的松片(参比制剂,商品名:Florinef®,规格:0.1mg)的药动学特征,评价两制剂间的生物等效性。
次要研究目的:
观察单次口服0.1mg的受试制剂醋酸氟氢可的松片(规格:0.1mg)或参比制剂醋酸氟氢可的松片(商品名:Florinef®,规格:0.1mg)在健康受试者中的安全性。
[Translation] Main research purposes:
This study investigated the single oral administration of fludrocortisone acetate tablets (test preparation, specification: 0.1 mg) provided by Jiangsu Fuzinyu Pharmaceutical Technology Co., Ltd. or Fluoroacetate produced by Aspenjiban Co., Ltd. under fasting and postprandial conditions. Pharmacokinetic characteristics of hydrocortisone tablets (reference preparation, trade name: Florinef®, strength: 0.1 mg), evaluation of bioequivalence between the two preparations.
Secondary research purposes:
Observe that a single oral dose of 0.1 mg of the test preparation fludrocortisone acetate tablet (specification: 0.1 mg) or the reference preparation fludrocortisone acetate tablet (trade name: Florinef®, specification: 0.1 mg) in healthy subjects security in the user.
醋酸氟氢可的松片在健康成年受试者中于餐后情况下进行单剂量、随机、开放性、双周期、双交叉生物等效性研究
[Translation] A single-dose, randomized, open-label, two-cycle, two-crossover bioequivalence study of fludrocortisone acetate tablets in healthy adult subjects after meals
主要研究目的:在健康男性和女性受试者中于餐后情况下评价醋酸氟氢可的松片和FLORINEF®的吸收速度和吸收程度,评价两制剂间是否具有生物等效性。 次要研究目的:评估受试制剂醋酸氟氢可的松片和参比制剂FLORINEF®在中国健康受试者中的安全性。
[Translation] MAIN STUDY OBJECTIVE: To evaluate the rate and extent of absorption of fludrocortisone acetate tablets and FLORINEF® in healthy male and female subjects under postprandial conditions, and to evaluate whether there is bioequivalence between the two formulations. Secondary study objectives: To evaluate the safety of the test preparation fludrocortisone acetate tablets and the reference preparation FLORINEF® in healthy Chinese subjects.
醋酸氟氢可的松片在健康成年受试者中于空腹情况下进行单剂量、随机、开放性、双周期、双交叉生物等效性研究
[Translation] A single-dose, randomized, open-label, two-cycle, two-crossover bioequivalence study of fludrocortisone acetate tablets in healthy adult subjects under fasting conditions
主要研究目的:在健康男性和女性受试者中于空腹情况下评价醋酸氟氢可的松片和FLORINEF®的吸收速度和吸收程度,评价两制剂间是否具有生物等效性。
次要研究目的:评估受试制剂醋酸氟氢可的松片和参比制剂FLORINEF®在中国健康受试者中的安全性。
[Translation] MAIN STUDY OBJECTIVE: To evaluate the rate and extent of absorption of fludrocortisone acetate tablets and FLORINEF® in healthy male and female subjects on an empty stomach, and to evaluate whether there is bioequivalence between the two preparations.
Secondary study objectives: To evaluate the safety of the test preparation fludrocortisone acetate tablets and the reference preparation FLORINEF® in healthy Chinese subjects.
100 Clinical Results associated with Jiangsu Fuzinyu Pharmaceutical Technology Co., Ltd.
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100 Translational Medicine associated with Jiangsu Fuzinyu Pharmaceutical Technology Co., Ltd.