Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

NCT05474053 | Completed Phase 3 DMC

• 1 other identifier: tica trial
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Brilique group

EXPERIMENTAL

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)

Ticaloguard group

EXPERIMENTAL

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)

Interventions

Ticagrelor 90mg (Brilique) DRUG

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

Also known as: Brilique

Brilique group

Ticagrelor 90mg (Ticaloguard) DRUG

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

Ticaloguard group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine

Cairo, 4262004, Egypt

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Nirmeen sabry, MD

  Faculty of pharmacy, Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: July 26, 2022
• Study Start: November 13, 2021
• Primary Completion: November 28, 2021
• Study Completion: November 28, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)