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

Cumberland Pharmaceuticals1 site in 1 country12 target enrollmentMarch 2009

ConditionsHealthy

InterventionsIVIb

DrugsIVIb

Overview

Phase: Phase 1
Intervention: IVIb
Conditions: Healthy
Sponsor: Cumberland Pharmaceuticals
Enrollment: 12
Locations: 1
Primary Endpoint: To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
Status: Completed
Last Updated: 11 years ago

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

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

June 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Sponsor

Cumberland Pharmaceuticals

Responsible Party

Sponsor

•Healthy volunteers between the ages of 18 and 65 years (at the time of consent).

•Participants lacking good venous access in both arms.
•History of allergy or hypersensitivity to NSAIDs or any component of intravenous ibuprofen.
•Have never taken aspirin or ibuprofen
•History of abuse of alcohol or other drugs in the 2 months before CTM administration.
•Have used prescription drugs (not including oral contraceptives) within 14 days before CTM administration or have used aspirin within one week before CTM administration or over-the-counter pain relievers (NSAIDs or acetaminophen) within 3 days before CTM administration.
•Have taken investigational drugs within 30 days before CTM administration.
•Have donated blood or blood products within 30 days before CTM administration.
•Be pregnant or nursing.
•Have had breast cancer.
•Have a clinically significant laboratory test