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Ibuprofen Bioavailability Trial With Oral Single Dose Administration.

NCT03018015 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-11

No results posted yet for this study

Summary

The present study will be conducted in order to assess bioequivalence of the Test product (Ibuprofen 400 mg oral powder) and the Reference product 1 (Brufen 400 mg film-coated tablet), an approved market product in the European Union. Testing for bioequivalence will be performed considering AUC0-tlast and Cmax obtained after oral single dose fasted administration of ibuprofen.

In addition to the conventional immediate release tablet used as Reference 1, a soft capsule formulation will be applied as Reference 2 (Spalt Forte 400 mg Weichkapseln), as an example for a product with a very fast absorption rate.

All 3 immediate release preparations contain 400 mg ibuprofen.

Conditions

  • Bioequivalence

Interventions

DRUG

Ibuprofen 400 mg oral powder

DRUG

Ibuprofen 400 mg film-coated tablet

DRUG

Ibuprofen 400 mg soft capsule

Sponsors & Collaborators

  • SocraMetrics GmbH

    collaborator INDUSTRY

  • SocraTec R&D GmbH

    lead OTHER

Principal Investigators

  • Cornelius Koch, MD · SocraTec R&D GmbH, Clinical Pharmacology Unit

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Germany

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 NCT03018015 on ClinicalTrials.gov