Overview

Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Unde

Status:
Completed

Trial end date:
2018-08-13

Target enrollment:

Participant gender:

Summary

This is an open-label, randomized, single-center, single-dose, two-treatment, two-sequence, two-period, crossover, comparative study, where each subject will be randomly assigned to the reference or the test formulation in each period of the study (sequences RT or TR), in order to evaluate if both formulations are bioequivalent.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborators:

ClinPharmInvest CRO
ClinPharmInvest, LLC

Treatments:

Amoxicillin-Potassium Clavulanate Combination