Overview

Bioequivalence Study of Sotalol, Tablets, 160 mg (Pharmtechnology LLC, Belarus), and Sotalex ®, Tablets, 160 mg (Bristol-Myers Squibb GmbH & Co. KGaA, Germany), in Healthy Volunteers Under Fasting Conditions

Status:
Completed

Trial end date:
2019-02-11

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 was 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.The study was conducted in multiple groups.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmtechnology LLC

Collaborator:

National Anti-Doping Labaratory

Treatments:

Sotalol