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Bioequivalence Study of Test and Reference 50 mg Eplerenone Film-coated Tablets in Healthy Volunteers

NCT05663372 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-12-23

No results posted yet for this study

Summary

This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Efez 50 mg eplerenone film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa", Ukraine) and Reference medicinal product (marketed medicinal product INSPRA® 50 mg eplerenone film-coated tablets, Marketing Authorisation Holder: Pfizer Europe MA EEIG, Belgium) in healthy volunteers.

Conditions

  • Bioequivalence
  • Healthy Subjects

Interventions

DRUG

Efez 50 mg eplerenone film-coated tablets

Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone

DRUG

INSPRA® 50 mg eplerenone film-coated tablets

Oral, mineralocorticoid receptor antagonist, a blocker of aldosterone

Sponsors & Collaborators

  • ACDIMA Biocenter

    collaborator OTHER

  • Darnitsa Pharmaceutical Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2021-12-28
Completion
2021-12-28

Countries

  • Jordan

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 NCT05663372 on ClinicalTrials.gov