他米巴罗汀片(OMS0728)治疗复发或难治性急性早幼粒细胞白血病(APL)的有效性、安全性验证试验
[Translation] Efficacy and safety validation trial of Tamibarotene tablets (OMS0728) in the treatment of relapsed or refractory acute promyelocytic leukemia (APL)
1. 以ATRA联用ATO为对照,评价OMS0728联用ATO治疗复发急性早幼粒细胞白血病(APL)的有效性、安全性 2. 评价OMS0728单剂治疗难治性急性早幼粒细胞白血病(APL)的有效性、安全性 3. 进行OMS0728药代动力学研究
[Translation] 1. To evaluate the efficacy and safety of OMS0728 combined with ATO in the treatment of relapsed acute promyelocytic leukemia (APL) using ATRA combined with ATO as a control 2. To evaluate the efficacy and safety of OMS0728 alone in the treatment of refractory acute promyelocytic leukemia (APL) 3. To conduct a pharmacokinetic study of OMS0728
TY-0201R的药代动力学试验
-以中国健康成年人为研究对象的4mg、8 mg单次给药试验及8mg多次给药试验-
[Translation] Pharmacokinetic study of TY-0201R
-4mg, 8mg single-dose study and 8mg multiple-dose study with healthy Chinese adults as research subjects-
以中国健康成年人为研究对象,探讨TY-0201R 4mg、8mg单次给药时及8mg 7天多次给药时的药代动力学以及安全性。
[Translation] Healthy Chinese adults were used as research subjects to explore the pharmacokinetics and safety of TY-0201R when administered as a single dose of 4 mg or 8 mg and when administered as multiple doses of 8 mg for 7 days.
评价TY-0201R在中国原发性高血压患者中有效性和安全性的III期临床试验
-以富马酸比索洛尔口服制剂为对照的双盲平行对照试验-
[Translation] Phase III clinical trial to evaluate the efficacy and safety of TY-0201R in Chinese patients with essential hypertension
-A double-blind parallel controlled trial with oral bisoprolol fumarate as a control-
以原发性高血压(1级或2级)患者为对象,给予TY-0201R 8mg或富马酸比索洛尔口服制剂(以下简称口服制剂)5mg,每日1次,给药8周。通过双盲双模拟、平行对照试验验证TY-0201R的有效性非劣于口服制剂,同时进行安全性评价。
[Translation] Patients with essential hypertension (grade 1 or 2) were given TY-0201R 8 mg or bisoprolol fumarate oral preparation (hereinafter referred to as oral preparation) 5 mg once a day for 8 weeks. The efficacy of TY-0201R was verified to be non-inferior to the oral preparation through a double-blind double-dummy, parallel controlled trial, and the safety was evaluated at the same time.
100 Clinical Results associated with Beijing CRO Co. Ltd.
0 Patents (Medical) associated with Beijing CRO Co. Ltd.
100 Deals associated with Beijing CRO Co. Ltd.
100 Translational Medicine associated with Beijing CRO Co. Ltd.