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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.CN |
First Approval Date17 Mar 2020 |
评价桑枝总生物碱片治疗2型糖尿病的有效性和安全性的IV期临床试验
[Translation] Phase IV clinical trial evaluating the efficacy and safety of mulberry alkaloid tablets in the treatment of type 2 diabetes mellitus
1)评价桑枝总生物碱片单药或联合其他降糖药物(此处并非严格意义上的联合用药,而是指在其他降糖药血糖控制不佳的基础上加用本品,并经临床医生根据药物作用的机理进行充分判断)治疗2型糖尿病的有效性;
2)观察受试者长期用药后的安全性;
3)探索桑枝总生物碱片治疗不同中医证候2型糖尿病的有效性和安全性(2型糖尿病中医证候分型仅在参加单位为中医院的中心进行)。
[Translation] 1) Evaluation of mulberry total alkaloid tablets alone or in combination with other hypoglycemic drugs (here is not a combination drug in the strict sense, but refers to the addition of this product on the basis of poor blood sugar control of other hypoglycemic drugs, and after Clinicians make full judgments based on the mechanism of drug action) the effectiveness of treating type 2 diabetes;
2) Observe the safety of subjects after long-term medication;
3) To explore the efficacy and safety of Sangzhi total alkaloid tablets in the treatment of different TCM syndromes of type 2 diabetes (TCM syndrome classification of type 2 diabetes is only carried out in the center of the participating unit is a traditional Chinese medicine hospital).
评价紫杉醇中/长链脂肪乳注射液(胆固醇结合型)治疗晚期实体瘤的安全性、耐受性、药代特征及有效性的多中心、开放Ⅰa期临床研究
[Translation] A multicenter, open-label phase Ia clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and efficacy of paclitaxel medium/long-chain fat emulsion injection (cholesterol-binding type) in the treatment of advanced solid tumors
主要目的
观察使用WH-002在晚期实体瘤患者中的安全性和耐受性。
确定晚期实体瘤患者使用WH-002的最大耐受剂量(maximal tolerated dose,MTD),后续推荐剂量(recommend dose,RD)和剂量限制性毒性(dose-limiting toxicity,DLT)。
次要目的
评估WH-002的药代动力学(pharmacokinetics,PK)特征。
初步观察WH-002的抗肿瘤活性。
[Translation] main purpose
To observe the safety and tolerability of the use of WH-002 in patients with advanced solid tumors.
To determine the maximal tolerated dose (MTD), follow-up recommended dose (RD) and dose-limiting toxicity (DLT) of WH-002 in patients with advanced solid tumors.
secondary purpose
The pharmacokinetics (PK) profile of WH-002 was assessed.
The antitumor activity of WH-002 was preliminarily observed.
100 Clinical Results associated with Beijing Wehand Bio Pharmaceutical Co., Ltd.
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