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A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects

NCT02256423 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-10-03

No results posted yet for this study

Summary

This is an open-label, randomised, 3-period, 3-sequence single-dose crossover study to determine the comparative pharmacokinetic profile of the Test Investigational Medicinal Product (IMP) Ibuprofen 200 mg soft gel capsule (lipid formulation) with that from the reference products Nurofen® 200 mg tablet and ibuprofen 200 mg soft gel capsule following single dose administration in healthy male and female subjects.

The study comprises of a pre-study screen (within 14 days of the first dose), followed by 3 Treatment Periods (1, 2 and 3) and a post study follow up (3 - 7 days after the last dose). Each Treatment Period is of 1 day in duration, from the afternoon before dosing (Day -1) until 12 hours (h) post-dose (Evening of Day 1). Study drug is administered on the morning of Day 1 following an overnight fast. PK samples will be collected pre-dose and up to 12 h post-dose (x15 samples) for the measurement of ibuprofen. Safety is evaluated at specified times throughout the study. There is at least 48 h between dose administrations.

Conditions

  • Healthy Volunteer Study

Interventions

DRUG

REFERENCE 1: Nurofen® 200 mg tablet

DRUG

REFERENCE 2: Ibuprofen 200 mg soft gel capsule

DRUG

ibuprofen 200 mg soft gel capsule

Sponsors & Collaborators

  • Simbec Research

    lead INDUSTRY

Principal Investigators

  • Girish Sharma, MBBS · Simbec Research

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
2014-07-31
Primary Completion
2014-08-31
Completion
2014-08-31

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 NCT02256423 on ClinicalTrials.gov