NCT00867880

Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Crossover Study of the Pharmacokinetics, Safety and Tolerability of Ibuprofen Inejction (IVIb) In Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IVIb	800mg IVIb diluted in 200mL NS will be given IV (in the vein) concurrently with an oral placebo on Day 1 and 200ml Normal Saline will be given IV (in the vein)concurrently with 800mg oral ibuprofen on Day 8

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2009-03-24
• Last updated: 2014-12-15

Locations

1 site across 1 country: Australia