NCT03429738

Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets

A Single-Dose, Comparative Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride 200 mg/30 mg Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.

Detailed description

Ibuprofen is one of the most often used non steroidal antiinflammatory drug (NSAR) in the management of mild to moderate pain and inflammation. Combined with the sympathomimetic pseudoephedrine as decongestant it is widely used in colds or fever. The purpose of this phase-I-study was to evaluate the comparative bioavailability between a combination of 200 mg ibuprofen and 30 mg pseudoephedrine film-coated tablets to the reference formulation RhinAdvil Rhume® 200 mg/30 mg (Wyeth Santé Familiale, France).

Conditions

• Pain, Head
• Pain, Acute
• Pain, Back
• Fever

Interventions

Type	Name	Description
DRUG	Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets	Experimental drug
DRUG	RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets	Active Comparator

Timeline

• Start date: 2014-04-27
• Primary completion: 2014-05-05
• Completion: 2014-05-05
• First posted: 2018-02-12
• Last updated: 2018-02-12

Locations

1 site across 1 country: Canada