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非在研适应症- |
最高研发阶段批准上市 |
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首次获批日期1978-08-17 |
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非在研适应症- |
最高研发阶段临床1期 |
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在研适应症- |
非在研适应症- |
最高研发阶段临床前 |
首次获批国家/地区- |
首次获批日期- |
A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel Forming Solution After Multiple Dosing in Healthy Subjects with That of Timolol Maleate Gel in Subjects with Proliferating Superficial Infantile Hemangioma Who Have Completed the Study
The goal of this clinical trial is:
1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects.
The main questions aim to answer are:
* Pharmacokinetic (PK) profiles of healthy adult subjects
* Safety Evaluation
* To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% timolol maleate gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% timolol maleate ophthalmic gel forming solution in healthy adult subjects.
中国健康受试者空腹和餐后单次口服阿哌沙班分散片和阿哌沙班片的随机、开放、两序列、两周期、双交叉设计的生物等效性研究
主要目的:
以上海奥全生物医药科技有限公司提供的阿哌沙班分散片为受试制剂(2.5 mg/片),以Bristol-Myers Squibb Manufacturing Company生产的阿哌沙班片(Eliquis®,2.5mg/片)为参比制剂,比较阿哌沙班分散片和阿哌沙班片在中国健康受试者体内的药代动力学(Pharmacokinetics,PK)行为,评价空腹和餐后口服两种制剂的生物等效性。
次要目的:
1、评价中国健康受试者空腹及餐后单次口服阿哌沙班分散片和阿哌沙班片的安全性。
2、收集受试者服用阿哌沙班分散片后15 min内的感官评估问卷(包含口感、口味以及服药后的余味)。
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Timolol Maleate Gel in the Treatment of Proliferating Superficial Infantile Hemangioma
The goal of this clinical trial is to evaluate the safety and efficacy of timolol maleate (TM) gel in subjects with superficial infantile hemangioma (IH) in the proliferative phase. The main question it aims to answer is:
• The primary endpoint (success or failure) assessment was a centralized and independent qualitative assessment based on blinded comparison on B-ultrasonography results and photographs of IH at W24 from baseline.
Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH.
Participants will:
* Take the study drug 3 times daily (once in the morning, noon, and evening, respectively) for 24 weeks.
* The family members of patients are instructed to bring the patients to the clinic for regular follow-up visits at Week 4 (W4), Week 12 (W12), and Week 24 (W24) of the treatment period.
* Keep a diary of concomitant medications and adverse events.
100 项与 上海奥全生物医药科技有限公司 相关的临床结果
0 项与 上海奥全生物医药科技有限公司 相关的专利(医药)
100 项与 上海奥全生物医药科技有限公司 相关的药物交易
100 项与 上海奥全生物医药科技有限公司 相关的转化医学