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Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study

NCT03184766 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-06-14

No results posted yet for this study

Summary

This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen \& 30 mg pseudoephedrine).

Conditions

  • Healthy

Interventions

DRUG

Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules

2 x 200 mg ibuprofen \& 30 mg pseudoephedrine

DRUG

Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets

2 x 200 mg ibuprofen \& 30 mg pseudoephedrine

DRUG

Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules

2 x 200 mg solubilised ibuprofen

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • Robert Adams, MBBS · Simbec Research

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
2016-08-10
Primary Completion
2017-01-30
Completion
2017-01-30

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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 NCT03184766 on ClinicalTrials.gov