drugset / Trial / NCT03184766
Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibuprofen | Small molecule | 400 mg | — |
| Subject | Pseudoephedrine | Small molecule | 30 mg | — |
Indications
No indication recorded.