Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

Summary

The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, \[roller compaction\] and \[wet granulation\] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.

Timeline

Start

2009-05-07

Primary completion

2009-08-01

Completion

2009-08-05

Drugs

Indications

No indication recorded.