Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
Status:
Completed
Trial end date:
2009-08-05
Target enrollment:
Participant gender:
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.