Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

Phase 3

Completed

• Conditions: Cardiovascular Diseases; Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor 90mg (Brilique); Drug: Ticagrelor 90mg (Ticaloguard)

• Registration Number: NCT05474053
• Lead Sponsor: Cairo University

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 Timeline

• Study Start: 2021-11-13
• Primary Completion: 2021-11-28
• Study Completion: 2021-11-28
• Status Verified: 2022-07
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-21
• Last Update Submitted: 2022-07-21
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

volunteers of both sexes, aged between 18-64 years old

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brilique group	Ticagrelor 90mg (Brilique)	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
Ticaloguard group	Ticagrelor 90mg (Ticaloguard)	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

Primary Outcome Measures

Name	Time	Method
testing degree of platelet inhibition of Ticalouguard versus the brand Brilique	1 month	Testing the degree of platelet inhibition in both groups through performing platelet aggregation testing using Adenosine diphosphate as agonist

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Cairo, Egypt