Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence
NCT05474053 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2022-07-26
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
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
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