drugset / Trial / NCT03184766

Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study

NCT03184766

RandomizedCrossoverOpen-labelOther

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).

Timeline

Start
2016-08-10
Primary completion
2017-01-30
Completion
2017-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 400 mg
Subject Pseudoephedrine Small molecule 30 mg

Indications

No indication recorded.