drugset / Trial / NCT03180879

Ibuprofen Bioavailability Study

NCT03180879

RandomizedCrossoverOpen-labelOther

Summary

This project is the in-house development of a 200 mg ibuprofen acid orodispersable tablet (ODT; meltlet). It is designed to appeal to consumers who want a dosage form that may be taken without water and can be used 'on the go'. Vanquish has an improved organoleptic profile compared to the currently marketed meltet by the Sponsor. ODTs are also considered as a suitable dosage form for children who may be reluctant to swallow tablets. This product has the potential for application in both adults and children due to the convenience of the format and the ease of administration for both groups. This will be the first pharmacokinetic (PK) assessment of the ibuprofen acid ODT formulation.

Timeline

Start
2017-04-10
Primary completion
2017-06-13
Completion
2017-06-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibuprofen Small molecule 400 mg Oral

Indications

No indication recorded.