The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
|Study Type:||Interventional (Clinical Trial)|
|Estimated Enrollment:||24 participants|
|Allocation:||Single Group Assignment|
|Intervention Model:||Multi-center, Open-label|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months|
|Actual Study Start Date:||July 17, 2017|
|Estimated Primary Completion Date:||December 2018|
|Estimated Study Completion Date:||December 2018|
|Contact: Byron Kaelin||615-255-0068 ext 250||[email protected]|
|Contact: Jerry Fox||615-255-0068 ext 226||[email protected]|
For enrollment please visit www.clinicaltrials.gov.