[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence trial evaluating the investigational formulation letrozole tablets (2.5 mg) versus the reference formulation letrozole tablets (Femara®, 2.5 mg) in healthy adult trial participants in fasting condition.

主要试验目的：研究空腹状态下单次口服受试制剂来曲唑片（规格：2.5 mg，Shin Poong Pharm. Co., Ltd.持证、Shin Poong Pharm. Co., Ltd.生产）与参比制剂来曲唑片（Femara®，规格：2.5 mg，Novartis Pharma Schweiz AG持证、Novartis Pharma Stein AG生产）在健康成年试验参与者体内的药代动力学，评价空腹状态下口服两种制剂的生物等效性。次要试验目的：评估受试制剂来曲唑片（规格：2.5 mg）和参比制剂来曲唑片（Femara®，规格：2.5 mg）在健康成年试验参与者中的安全性。

[Translation]

Primary objective: To investigate the pharmacokinetics of a single oral dose of the test formulation letrozole tablets (2.5 mg, licensed and manufactured by Shin Poong Pharm. Co., Ltd.) and the reference formulation letrozole tablets (Femara®, 2.5 mg, licensed and manufactured by Novartis Pharma Schweiz AG) in healthy adult participants under fasting conditions, and to evaluate the bioequivalence of the two formulations under fasting conditions. Secondary objective: To assess the safety of the test formulation letrozole tablets (2.5 mg) and the reference formulation letrozole tablets (Femara®, 2.5 mg) in healthy adult participants.

Start Date12 Sep 2026

Sponsor / Collaborator

Beijing Hua Xi Lianhe Tech & Development Ltd.

CTR20131777

/ CompletedPhase 2

色甘赛洛鼻喷雾剂治疗过敏性鼻炎多中心、随机双盲双模拟、阳性药平行对照临床研究

[Translation] A multicenter, randomized, double-blind, double-dummy, positive-drug parallel-controlled clinical study of crogancel nasal spray in the treatment of allergic rhinitis

评价色甘赛洛鼻喷雾剂治疗过敏性鼻炎的安全性和有效性。

[Translation]

To evaluate the safety and efficacy of cromoglucose nasal spray in the treatment of allergic rhinitis.

Start Date28 Mar 2008

Sponsor / Collaborator

Beijing Hua Xi Lianhe Tech & Development Ltd.

CTR20130673

/ Not yet recruitingPhase 1

阿莫西林氨溴索胶囊人体药代动力学Ⅰ期临床试验

[Translation] Phase I Clinical Trial on the Pharmacokinetics of Amoxicillin and Ambroxol Capsules in Humans

研究本公司研制的阿莫西林氨溴索胶囊在健康成人体内的药代动力学特性。

[Translation]

To study the pharmacokinetic properties of amoxicillin-ambroxol capsules developed by our company in healthy adults.

Start Date-

Sponsor / Collaborator

Beijing Hua Xi Lianhe Tech & Development Ltd.

100 Clinical Results associated with Beijing Hua Xi Lianhe Tech & Development Ltd.

0 Patents (Medical) associated with Beijing Hua Xi Lianhe Tech & Development Ltd.

100 Deals associated with Beijing Hua Xi Lianhe Tech & Development Ltd.

100 Translational Medicine associated with Beijing Hua Xi Lianhe Tech & Development Ltd.

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