Overview

Bioequivalence Study of Two Formulations of Atorvastatin Film-coated Tablets 40 mg in Healthy Volunteers Under Fasting Conditions

Status:
Recruiting

Trial end date:
2022-12-20

Target enrollment:

Participant gender:

Summary

This is an open-labeled, randomized, two period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Liprimar®, 40 mg film-coated tablets) or the test (Atorvastatin, 40 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:

Atorvastatin