Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Acute Coronary Syndrome
• Intervention / Treatment: Drug: Ticagrelor 90mg (Brilique); Drug: Ticagrelor 90mg (Ticaloguard)

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 4262004
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Ticagrelor 90mg (Brilique); compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers; Other Names: Brilique
Experimental: 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	Drug: Ticagrelor 90mg (Ticaloguard); compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Nirmeen sabry, MD, Faculty of Pharmacy, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2021
• Primary Completion (Actual): November 28, 2021
• Study Completion (Actual): November 28, 2021

Study Registration Dates

• First Submitted: July 19, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Vascular Diseases; Cardiovascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor
• Other Study ID Numbers: tica trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No