MedTrace Logo

Ibuprofen 4% (w/v) Pivotal Bioequivalence Study

NCT03496324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-06-05

Study results available
· View outcomes & findings →

Summary

Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor® Junior by determining and comparing the rate and extent of absorption in both fed and fasted states

Conditions

  • Bioequivalence of the Test Formulation

Interventions

DRUG

Nurofen for Children®

Nurofen for Children® 400 mg/10 ml

DRUG

Algifor® Junior

Algifor® Junior 400 mg/20 ml

Sponsors & Collaborators

  • Reckitt Benckiser Healthcare (UK) Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-05-06
Completion
2016-05-06

More Related Trials

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 NCT03496324 on ClinicalTrials.gov