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

Cumberland Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: IVIb

Study type

Interventional

Funder types

Industry

Identifiers

NCT00867880

CPI-CL-011

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Presence or history of the following conditions: asthma, bleeding tendency, hypertension, heart failure, peptic ulcer disease, inflammatory bowel disease, or any other gastrointestinal disorder, renal or hepatic disease..
Have a calculated creatinine clearance (estimated by means of the Cockcroft-Gault equation) of < 75mL/min
Inability to understand the requirements of the study. Participants must be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]), and agree to abide by the study restrictions.
Refusal to provide written authorization for use and disclosure of protected health information
Be otherwise unsuitable for the study, in the opinion of the Investigator.