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Ibuprofen Bioavailability Study

NCT03180879 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2017-10-05

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Test - RB ibuprofen acid orodispersible tablets

RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.

DRUG

Reference - RB Nurofen ibuprofen acid tablets

RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.

DRUG

Comparator - Dolormin ibuprofen lysine tablets

Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

Sponsors & Collaborators

  • Simbec Research

    collaborator INDUSTRY

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Principal Investigators

  • Annelize Koch, 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
2017-04-10
Primary Completion
2017-06-13
Completion
2017-06-13

Countries

  • United Kingdom

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 NCT03180879 on ClinicalTrials.gov