NCT02256423

A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects

A Single-dose, Randomised, Crossover Study to Compare the Pharmacokinetics of Three Formulations of Ibuprofen in Healthy Fasting Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Simbec Research · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	REFERENCE 1: Nurofen® 200 mg tablet
DRUG	REFERENCE 2: Ibuprofen 200 mg soft gel capsule
DRUG	ibuprofen 200 mg soft gel capsule

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-10-03
• Last updated: 2014-10-03

Locations

1 site across 1 country: United Kingdom