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NCT03180879

Ibuprofen Bioavailability Study

Completed Phase 1 Last updated 5 October 2017
What this trial tests

Phase 1 trial testing Test - RB ibuprofen acid orodispersible tablets in Healthy in 36 participants. Completed in 13 June 2017.

Timeline
10 April 2017
Primary endpoint
13 June 2017
13 June 2017

Quick facts

Lead sponsorReckitt Benckiser Healthcare (UK) Limited
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment36
Start date10 April 2017
Primary completion13 June 2017
Estimated completion13 June 2017
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Reckitt Benckiser Healthcare (UK) Limited — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparative Bioavailability Study of a New Orodispersible Formulation of Ibuprofen Versus Two Existing Oral Tablet Formulations in Healthy Male and Female Volunteers.
    Sugár D, Francombe D, da Silva T, Hanid S, et al · · 2019 · cited 4× · PMID 31202508 · DOI 10.1016/j.clinthera.2019.04.040

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Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Reckitt Benckiser Healthcare (UK) Limited trials

Trials by the same sponsor.

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Data sources for this page

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