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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

NCT03799536 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-06-07

No results posted yet for this study

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.

Conditions

  • Bioequivalence

Interventions

DRUG

Sotalol

Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus

DRUG

Sotalex

Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH \& Co. KGaA, Germany

Sponsors & Collaborators

  • National Anti-Doping Labaratory

    collaborator UNKNOWN

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Anastasia Teteryukova, MD · National Anti-Doping Labaratory

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2019-02-04
Completion
2019-02-11

Countries

  • Belarus

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03799536 on ClinicalTrials.gov