Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Acute Coronary Syndrome; Cardiovascular Diseases

Treatments: Drug: Ticagrelor 90mg (Ticaloguard); Drug: Ticagrelor 90mg (Brilique)

Study type: Interventional

Funder types: Other

Identifiers

NCT05474053

tica trial

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 29 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups

Brilique group

Experimental group

Description:

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

Treatment:

Drug: Ticagrelor 90mg (Brilique)

Ticaloguard group

Experimental group

Description:

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

Treatment:

Drug: Ticagrelor 90mg (Ticaloguard)