Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

NCT05474053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2022-07-26

No results posted yet for this study

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

Interventions

DRUG

Ticagrelor 90mg (Brilique)

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

DRUG

Ticagrelor 90mg (Ticaloguard)

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Nirmeen sabry, MD · Faculty of pharmacy, Cairo university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-13
Primary Completion
2021-11-28
Completion
2021-11-28

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05474053 on ClinicalTrials.gov