Testing P2Y12 Platelet Inhibitors Generics Beyond Bioequivalence

• Status: Completed
• Trial end date: 2021-11-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cairo University
• Treatments: Ticagrelor

Criteria

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.