Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

Cardiovascular Diseases Clinical Trial

Official title:

Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence: A Parallel Single-blinded Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05474053
• Other study ID #: tica trial
• Status: Completed
• Phase: Phase 3
• Start date: November 13, 2021
• Est. completion date: November 28, 2021

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 28, 2021
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cardiovascular Diseases

Intervention

Drug:
• Ticagrelor 90mg (Brilique)
compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers
• Ticagrelor 90mg (Ticaloguard)
compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	testing degree of platelet inhibition of Ticalouguard versus the brand Brilique	Testing the degree of platelet inhibition in both groups through performing platelet aggregation testing using Adenosine diphosphate as agonist	1 month