NCT01316978

A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments

A Single-Dose, Randomised, Crossover Bioequivalence Study to Compare the Rate and Extent of Absorption of a Test Formulation of Ibuprofen Fast Melt Orodispersible Tablet Versus Two Reference Formulations in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.

Detailed description

The study is a single dose, randomized, three-way crossover study in 30 healthy subjects, with equal numbers of males and females (minimum of 13 of either gender). Drop-outs will not be replaced. The three doses of medication given in the study (a single dose in each of the three study periods) will each be separated by a washout period of at least 7 calendar days. In each study period, eighteen (18) blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of ibuprofen (R-enantiomer and S-enantiomer) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data \[R-enantiomer, S-enantiomer and total (sum of both enantiomers)\]. The rate and extent of absorption of the formulations will be compared.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Ibuprofen	A single 2 x 100 mg dose of an experimental Ibuprofen Fast Melt Orodispersible Tablet administered orally, with a 7-day washout between visits
DRUG	Ibuprofen	A single 200 mg Nurofen Meltlets Orodispersible Tablet administered orally, with a 7-day washout between visits
DRUG	Ibuprofen	A single 2 x 100 mg dose of Junior Strength Motrin Chewable Tablet administered orally, with a 7-day washout between visits

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-03-16
• Last updated: 2012-07-10

Locations

1 site across 1 country: Canada