NCT03184766

Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study

An Open-label, Randomised, Three-way Cross-over, Single Dose, Single Centre, Comparative Pharmacokinetic Study Between Ibuprofen and Pseudoephedrine Liquid Capsules (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Test), Ibuprofen and Pseudoephedrine Tablets (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Comparator 1), and Ibuprofen Liquid Capsules (2x 200 mg Solubilised Ibuprofen) (Comparator 2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen \& 30 mg pseudoephedrine).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules	2 x 200 mg ibuprofen \& 30 mg pseudoephedrine
DRUG	Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets	2 x 200 mg ibuprofen \& 30 mg pseudoephedrine
DRUG	Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules	2 x 200 mg solubilised ibuprofen

Timeline

• Start date: 2016-08-10
• Primary completion: 2017-01-30
• Completion: 2017-01-30
• First posted: 2017-06-14
• Last updated: 2017-06-14