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Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers

NCT05663398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

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 (Darfen 400, 400 mg ibuprofen coated tablets \[512 mg ibuprofen sodium dihydrate\], manufactured by PrJSC "Pharmaceutical firm "Darnitsa" \[Ukraine\]) and Reference medicinal product (marketed medicinal product Nurofen® Forte Express, 400 mg ibuprofen coated tablets \[512 mg ibuprofen sodium dihydrate\], manufactured by Reckitt Benckiser \[Poland\] S.A.) in healthy volunteers.

Conditions

  • Bioequivalence
  • Healthy Subjects

Interventions

DRUG

Darfen 400, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate)

Oral, a nonsteroidal anti-inflammatory drug

DRUG

Nurofen® Forte Express, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate)

Oral, a nonsteroidal anti-inflammatory drug

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
2022-05-17
Primary Completion
2022-05-31
Completion
2022-05-31

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 NCT05663398 on ClinicalTrials.gov