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Bioequivalence of Ibuprofen vs Alivium in Healthy Volunteers

NCT01350596Phase 4

Key facts

Status: Completed
Start: May 2011
Primary completion: May 2011
Countries: 1
Sponsor: Pfizer
Modality: Small Molecules

Drugs: ibuprofen
Conditions: painfeverinflammation

Overview

Phase 4, randomised, open-label trial of ibuprofen in pain, fever and inflammation (2 arms), sponsored by Pfizer. Primary endpoints: Peak Plasma Concentration and Area under the plasma concentration versus time curve from time zero to the last measurable concentration. Started May 2011; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Reference Drug (Alivium)
Alivium 50mg/mL oral suspension
Test Drug (Ibuprofen)
Pfizer Ibuprofen 50mg/mL oral suspension

Who it enrols

Healthy male or female volunteers aged 18-55 with BMI 18.5-28.63 and weight >50kg. Excludes those with significant medical history, drug/alcohol abuse, or recent investigational drug use.

Endpoints

Primary

Peak Plasma ConcentrationUp to 16h
Area under the plasma concentration versus time curve from time zero to the last measurable concentrationUp to 16h

Secondary

Area under the plasma concentration versus time curve from time zero to infinityUp to 16h
Time to peak concentrationUp to 16h
Half-lifeUp to 16h
Elimination rate constantUp to 16h

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