[Translation] Clinical Study on Bioequivalence of Levothyroxine Sodium Tablets in Healthy Humans
研究目的:在中国健康受试者中,评价左甲状腺素钠片(受试制剂,商品名:雷替斯®)和左甲状腺素钠片(参比制剂,商品名:优甲乐®)的生物等效性。
主要目的:
以T4的主要药代动力学参数(Cmax、AUC0-72h、AUC0-∞)为评价指标,评价左甲状腺素钠片(受试制剂,商品名:雷替斯®)和左甲状腺素钠片(参比制剂,商品名:优甲乐®)的生物等效性。
次要目的:
评价左甲状腺素钠片的次要药代动力学参数:各周期用药后经基线校正后的T4和T3的CL/F、Vd/F、t1/2、Tmax、λz及T3的Cmax、AUC0-72h、AUC0-∞;
评价健康受试者服用左甲状腺素钠片(雷替斯®)和左甲状腺素钠片(优甲乐®)的安全性。
[Translation] Objective: To evaluate the efficacy of levothyroxine sodium tablets (test preparation, trade name: Letis®) and levothyroxine sodium tablets (reference preparation, trade name: Euthyrox®) in healthy Chinese subjects Bioequivalence.
main purpose:
Taking the main pharmacokinetic parameters of T4 (Cmax, AUC0-72h, AUC0-∞) as evaluation indicators, the evaluation of levothyroxine sodium tablets (test preparation, trade name: Ratis ® ) and levothyroxine sodium tablets ( Bioequivalence of the reference preparation, trade name: Eugene®).
Secondary purpose:
To evaluate the secondary pharmacokinetic parameters of levothyroxine sodium tablets: CL/F, Vd/F, t1/2, Tmax, λz and T3 Cmax, AUC0- 72h, AUC0-∞;
To evaluate the safety of levothyroxine sodium tablets (Ratis®) and levothyroxine sodium tablets (Uthyrox®) in healthy subjects.
一项在中国健康受试者中评价奈必洛尔 5 mg 单次和多次给药后药代动力学和安全性的单中心、开放设计的I 期研究。
[Translation] A single-center, open-label, phase I study to evaluate the pharmacokinetics and safety of nebivolol 5 mg following single and multiple doses in healthy Chinese subjects.
主要目的:在中国健康成年受试者中评价奈必洛尔 5 mg 单次给药和多次给药后的 PK 特征。
次要目的:在中国健康成年受试者中评估奈必洛尔 5 mg 单次和多次给药后的安全性和耐受性。
[Translation] Main objective: To evaluate the PK profile of nebivolol 5 mg following single and multiple doses in healthy Chinese adult subjects.
Secondary objective: To evaluate the safety and tolerability of nebivolol 5 mg following single and multiple doses in healthy Chinese adult subjects.
一项随机、双盲、双模拟、多中心、活性药物对照比较奈必洛尔与比索洛尔在中国 轻度至中度原发性高血压患者中的疗效与安全性的 III 期研究
[Translation] A randomized, double-blind, double-dummy, multicenter, active-controlled phase III study comparing the efficacy and safety of nebivolol and bisoprolol in Chinese patients with mild to moderate essential hypertension
这项研究旨在评估奈必洛尔相较于比索洛尔在治疗患有轻度至中度高血压的中国患者时的疗效的非劣效性与安全性。 主要目的:评估奈必洛尔相较于比索洛尔在治疗轻度至中度原发性高血压患者中的抗高血压疗效的非劣效性。 次要目的:评估奈必洛尔相较于比索洛尔在轻度至中度高血压患者中的安全性。
[Translation] This study was designed to evaluate the non-inferiority and safety of nebivolol compared to bisoprolol in Chinese patients with mild to moderate hypertension. Main objective: To evaluate the non-inferiority of nebivolol compared with bisoprolol for the antihypertensive efficacy in patients with mild to moderate essential hypertension. Secondary objective: To assess the safety of nebivolol compared to bisoprolol in patients with mild to moderate hypertension.
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