NCT03180879

Ibuprofen Bioavailability Study

An Open Label, Randomised, Single Dose, Three-way Crossover Study to Compare the Bioavailability of 400 mg Ibuprofen From 2 x 200 mg Ibuprofen Acid Orodispersable Tablets, 2x 200 mg Ibuprofen Acid Tablets and 2 x 342 mg Ibuprofen Lysine Tablets in Fasted Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Test - RB ibuprofen acid orodispersible tablets	RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.
DRUG	Reference - RB Nurofen ibuprofen acid tablets	RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.
DRUG	Comparator - Dolormin ibuprofen lysine tablets	Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.

Timeline

• Start date: 2017-04-10
• Primary completion: 2017-06-13
• Completion: 2017-06-13
• First posted: 2017-06-08
• Last updated: 2017-10-05

Locations

1 site across 1 country: United Kingdom