Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence: A Parallel Single-blinded Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- testing degree of platelet inhibition of Ticalouguard versus the brand Brilique
研究概览
简要总结
This is a pilot study that was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. we advocate comparing the clinical efficacy rather than simple bioequivalence comparison.
详细描述
Cardiovascular diseases are the leading cause of death worldwide. Ticagrelor, is an oral antiplatelet drug used in acute coronary syndrome. Although generic drugs are approved for their bioequivalence to the original product, they are not necessarily to be therapeutically equivalent. This study was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. A loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in Ticaloguard and Brilique groups, respectively. The platelet aggregation on adenosine diphosphate (ADP) agonist was assessed at different time intervals .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The volunteers were randomly allocated to 2 groups, one receiving the brand drug and the other receiving the generic, each receiving a code indicating his/her group and the key of the codes could only be revealed by the principal investigator.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •volunteers of both sexes, aged between 18-64 years old
排除标准
- •volunteers with any abnormalities in the complete blood count (CBC) at entry time
- •those with any medical conditions contraindicated with antiplatelet therapy
- •those taking aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or any over the counter medications (OTC) that contain medication such as, antihistamines, antibiotics in the previous month
- •volunteers with history of blood disorders or bleeding diathesis.
研究组 & 干预措施
Brilique group
volunteers in the Brilique group received a loading dose of 180 mg brand Brilique® (AstraZeneca , Sweden) then 90 mg twice daily regimen for 4 days
干预措施: Ticagrelor 90mg (Brilique) (Drug)
Ticaloguard group
volunteers in the Ticaloguard group received the Egyptian made generic ticalogaurd in a loading dose of 180 mg then 90 mg twice daily regimen for 4 day
干预措施: Ticagrelor 90mg (Ticaloguard) (Drug)
结局指标
主要结局
testing degree of platelet inhibition of Ticalouguard versus the brand Brilique
时间窗: 1 month
Testing the degree of platelet inhibition in both groups through performing platelet aggregation testing using Adenosine diphosphate as agonist
次要结局
未报告次要终点
研究者
Eman Said
Principal investigator
Cairo University