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Completed

NCT Number: NCT05474053

Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

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.

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Key information

Conditions

Cardiovascular Diseases Acute Coronary Syndrome Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine

Cairo, 4262004, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ticagrelor 90mg (Brilique)

Drug

compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers

Other names: Brilique

Ticagrelor 90mg (Ticaloguard)

Drug

compare the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2022
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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