A single-center, randomized, open, single-dose trial method was used to conduct an interaction trial (PK-PD) between batifiban injection and commonly used clinical combination drugs in Chinese healthy volunteers to clarify the impact of their pharmacokinetic and pharmacodynamic effects and provide a reference for the Phase II or III clinical dosage.

Start Date10 Jan 2019

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

CTR20130809 / CompletedPhase 3

巴替非班注射液用于接收PCI治疗的ACS患者的有效性和安全性的多中心随机双盲，安慰剂平行对照的III期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial on the efficacy and safety of Batifiban injection in patients with ACS undergoing PCI

确证巴替非班注射液用于ACS患者PCI术中和术后抗血栓治疗的有效性和安全性

[Translation]

To confirm the efficacy and safety of Batifiban injection in the antithrombotic treatment of ACS patients during and after PCI

Start Date31 Dec 2012

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

CTR20130814 / CompletedPhase 3

确证巴替非班注射液用于接受PCI治疗的ACS患者的有效性和安全性的多中心随机双盲安慰剂平行对照的Ⅲ期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to confirm the efficacy and safety of Batifiban injection in ACS patients undergoing PCI

确证巴替非班注射液用于ACS患者PCI术中、术后抗血栓治疗的有效性和安全性

[Translation]

To confirm the effectiveness and safety of Batifiban injection in the antithrombotic treatment of ACS patients during and after PCI

Start Date31 Dec 2012

Sponsor / Collaborator

Bio-Thera Solutions, Ltd.

100 Clinical Results associated with Batifiban

100 Translational Medicine associated with Batifiban

100 Patents (Medical) associated with Batifiban

Literatures (Medical) associated with Batifiban

01 Oct 2013·Journal of Huazhong University of Science and Technology [Medical Sciences]

Pharmacokinetic and pharmacodynamic properties of batifiban coadministered with antithrombin agents in Chinese healthy volunteers

Article

Author: Liu, Ming-Zhou ; Wang, Yao-Hua ; Zhou, Ying ; Li, Sheng-Feng ; Jia, Meng-Meng ; Li, Jie ; Chen, Ke ; Wu, San-Lan ; Chen, Hui ; Li, Wei-Yong ; He, Xiao-Meng

The combined use of batifiban, a synthetic platelet GPII b/ IIIa receptor antagonist, and antithrombin agents is an attractive option for the treatment of patients with non-ST-segment elevation (NSTE) acute coronary syndrome (ACS) and those scheduled for percutaneous coronary intervention. To observe whether antithrombin agents affect the pharmacokinetic and pharmacodynamic properties of batifiban in combination therapy and optimize clinical administration dosage of batifiban, an open-label and parallel study was conducted. Thirty healthy subjects were randomly divided into three groups, which were sequentially treated with batifiban alone, or oral coadministration of clopidogrel, aspirin and UFH, or batifiban coadministered with these antithrombin agents. Blood samples were collected at pre-specified time points. The evaluation index included the inhibition of platelet aggregation and pharmacokinetic parameters. The pharmacokinetic parameters of batifiban and batifiban coadministered with antithrombin agents showed no significant differences. The mean inhibition rate of platelet aggregation (%) suggested that neither batifiban alone nor antithrombin agents alone could provide such potent inhibition rate (>80%) to obtain the best clinical efficacy, but they had a synergistic effect on platelet inhibition. No serious adverse effects were observed. The results in these healthy subjects suggest that batifiban coadministrated with antithrombin agents could achieve optimum clinical treatment effect for patients with NSTE ACS, and also those scheduled for percutaneous coronary intervention.

01 Feb 2009·Journal of Huazhong University of Science and Technology [Medical Sciences]

Safety, pharmacokinetic and pharmacodynamic studies of batifiban injection following single- and multiple-dose administration to healthy Chinese subjects

Article

Author: Tao Guo ; Zhirong Tan ; Qian Li ; Jungang Deng ; Weiyong Li ; Hui Chen ; Jian Qiao

Batifiban, a synthetic cyclic peptide, is a potent platelet glycoprotein GPIIb/IIIa antagonist which may be useful in the treatment and prevention of acute coronary syndromes. The pharmacokinetics and pharmacodymanic (inhibition of platelet aggregation) effects, and tolerability of batifiban were investigated in healthy subjects following single bolus injection with doses of 55, 110, or 220 microg/kg, or multiple doses of an bolus followed intravenous infusion for 24 h (180 microg/kg plus 2.0 microg/min.kg, and 220 microg/kg plus 2.5 microg/min.kg) in this phase I clinical trial. Plasma levels of batifiban and areas under the curve were found to be proportional to doses. Batifiban was rapidly eliminated with a half-life of approximately 2.5 h. Significant differences were noted for plasma levels of batifiban and areas under the curve between males and females. No significant differences in the terminal half-life were found between males and females. Batifiban reversibly inhibited ex vivo platelet aggregation in a dose- and concentration-dependent manner, consistent with its mechanism as a GPIIb/IIIa antagonist. Single and multiple intravenous doses of batifiban were found to be safe and well tolerated in healthy subjects. These results support a bolus injection plus intravenous infusion regimen of batifiban for the treatment and prevention of acute coronary syndromes.

100 Deals associated with Batifiban

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Coronary Syndrome	CN	Bio-Thera Solutions, Ltd.	25 Jun 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-Q wave myocardial infarction	Phase 2	CN	Bio-Thera Solutions, Ltd.	31 Dec 2012
Angina, Unstable	Phase 1	CN	Bio-Thera Solutions, Ltd.	31 Dec 2012
Non-St Elevated Myocardial Infarction	Phase 1	CN	Bio-Thera Solutions, Ltd.	31 Dec 2012
Thrombosis	Phase 1	CN	Bio-Thera Solutions, Ltd.	31 Dec 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTR20180276 (Company_Website) Manual	Phase 2	Acute Coronary Syndrome	-	枸橼酸倍维巴肽	(skuocuhvqb) = 相比安慰剂组，枸橼酸倍维巴肽给药后血小板聚集抑制率快速达到80%以上，并在恒速滴定时保持稳定，给药结束后迅速恢复血小板聚集功能。 txzrzviinr (xshxhhioyo )	Positive	28 Jun 2024
				Placebo
CTR20130814 \| CTR20130809 (Company_Website) Manual	Phase 3	Acute Coronary Syndrome	-	枸橼酸倍维巴肽注射液	(afiquilycj) = 枸橼酸倍维巴肽注射液在现有标准治疗的基础上进一步降低发生复合终点事件风险超过43%。 ufkobmults (otrshypocu )	Positive	28 Jun 2024
				安慰剂

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