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Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT05474053
Collaborator
(none)
29
Enrollment
1
Location
2
Arms
15
Actual Duration (Days)
58.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ticagrelor 90mg (Brilique)
  • Drug: Ticagrelor 90mg (Ticaloguard)
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
The volunteers were randomly allocated to 2 groups, one receiving the brand drug and the other receiving the generic, each receiving a code indicating his/her group and the key of the codes could only be revealed by the principal investigator.
Primary Purpose:
Treatment
Official Title:
Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence: A Parallel Single-blinded Randomized Trial
Actual Study Start Date :
Nov 13, 2021
Actual Primary Completion Date :
Nov 28, 2021
Actual Study Completion Date :
Nov 28, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Cairo Egypt 4262004

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Nirmeen sabry, MD, Faculty of pharmacy, Cairo university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eman Said, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05474053
    Other Study ID Numbers:
    • tica trial
    First Posted:
    Jul 26, 2022
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Acute Coronary Syndrome
    Ticagrelor

    Study Results

    No Results Posted as of Jul 26, 2022