Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence: A Parallel Single-blinded Randomized Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- testing degree of platelet inhibition of Ticalouguard versus the brand Brilique
Study Overview
Brief Summary
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.
Detailed Description
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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •volunteers of both sexes, aged between 18-64 years old
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: 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
Intervention: Ticagrelor 90mg (Ticaloguard) (Drug)
Outcomes
Primary Outcomes
testing degree of platelet inhibition of Ticalouguard versus the brand Brilique
Time Frame: 1 month
Testing the degree of platelet inhibition in both groups through performing platelet aggregation testing using Adenosine diphosphate as agonist
Secondary Outcomes
No secondary outcomes reported
Investigators
Eman Said
Principal investigator
Cairo University