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Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmithKline Trading CJSC, Russia), in Healthy Volunteers Under Fasting Conditions

NCT03702894 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-05-14

No results posted yet for this study

Summary

This was 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

Clavamox

Clavamox, Film-coated Tablets, 875 mg + 125 mg, manufactured by Pharmtechnology LLC, Belarus

DRUG

Augmentin®

Augmentin®, Film-coated Tablets, 875 mg + 125 mg, marketed by GlaxoSmithKline Trading CJSC, Russia

Sponsors & Collaborators

  • ClinPharmInvest, LLC

    collaborator OTHER

  • Pharmtechnology LLC

    lead INDUSTRY

Principal Investigators

  • Alexander Khokhlov, Professor · ClinPharmInvest, LLC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2018-10-08
Completion
2018-10-08

Countries

  • Russia

Study Locations

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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 NCT03702894 on ClinicalTrials.gov