Overview

Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions

Status:
Completed

Trial end date:
2023-10-10

Target enrollment:

Participant gender:

Summary

This is an open-labeled, randomized, four period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Plavix®, 75 mg film-coated tablets) or the test (Clopidogrel, 75 mg film-coated tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborator:

ClinPharmInvest, LLC

Treatments:

Clopidogrel