[Translation] A phase I clinical study to evaluate the safety, tolerability, and pharmacokinetics of multiple-dose tadalafil tablets in healthy Chinese subjects

主要目的评价中国健康受试者多次口服泰格列净片后的安全性和耐受性及药代动力学特征。次要目的评价泰格列净片在健康人体内的药效学指标变化，推荐II 期临床试验的剂量。

[Translation]

Primary objective To evaluate the safety, tolerability and pharmacokinetic characteristics of Tagliflozin tablets after multiple oral administration in healthy Chinese subjects. Secondary objective To evaluate the changes in pharmacodynamic indicators of Tagliflozin tablets in healthy subjects and recommend the dose for Phase II clinical trials.

Start Date-

Sponsor / Collaborator

Tianjin Institute of Pharmaceutical Research Co., Ltd.

CTR20201558 / Not yet recruitingPhase 2

评价泰格列净片在2型糖尿病患者体内单次及多次给药的安全性、耐受性、药代动力学、药效学的Ib/IIa期临床研究

[Translation] Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of tagliflozin tablets in patients with type 2 diabetes

主要目的评价2型糖尿病患者单次及多次口服泰格列净片后的安全性、耐受性及药代动力学和药效学特征。次要目的初步评价泰格列净片对2型糖尿病患者的治疗作用，为后期临床试验推荐剂量。

[Translation]

Primary objective: To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of Tagliflozin tablets after single and multiple oral administration in patients with type 2 diabetes. Secondary objective: To preliminarily evaluate the therapeutic effect of Tagliflozin tablets on patients with type 2 diabetes and to recommend the dosage for later clinical trials.

Start Date-

Sponsor / Collaborator

Tianjin Institute of Pharmaceutical Research Co., Ltd.

CTR20181670 / CompletedPhase 1

评价在健康受试者体内的泰格列净片随机、双盲、安慰剂对照、单剂量递增的安全性I期临床研究

[Translation] A randomized, double-blind, placebo-controlled, single-dose ascending safety phase I clinical study to evaluate the efficacy of tagliflozin tablets in healthy subjects

主要目的: 评价中国健康受试者单次口服泰格列净片后的安全性和耐受性及药代动力学特征。次要目的: 初步评价在健康人体内的药效学指标变化，同时为多次给药耐受试验以及II期临床试验设计提供依据。

[Translation]

Primary objective: To evaluate the safety, tolerability and pharmacokinetic characteristics of Tagliflozin tablets after a single oral administration in healthy Chinese subjects. Secondary objective: To preliminarily evaluate the changes in pharmacodynamic indicators in healthy humans and provide a basis for multiple dosing tolerance tests and Phase II clinical trial design.

Start Date25 Sep 2018

Sponsor / Collaborator

Tianjin Institute of Pharmaceutical Research Co., Ltd.

100 Clinical Results associated with Tianagliflozin

100 Translational Medicine associated with Tianagliflozin

100 Patents (Medical) associated with Tianagliflozin

100 Deals associated with Tianagliflozin

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	CN	Tianjin Institute of Pharmaceutical Research Co., Ltd.	10 Aug 2020

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