A study to determine the safety, tolerability and process by which ibuprofen is absorbed, distributed, metabolized, and eliminated by the body over a 5-7 minute infusion.
- Conditions
- ThrombophlebitisInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12609000309280
- Lead Sponsor
- Cumberland Pharmaceuticals Incorparated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
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 Non-Steroidal Anti-Inflammatory Drugs (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes by doing blood analysis.[Predose, Immediately after<br>completion of the intravenous Clinical Trial Material (CTM) administration then at Hours 0.25,<br>0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10 and 12 hours after treatment.]
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of a single dose of IVIb by assessing the<br>frequency, severity and duration of treatment-emergent adverse events,<br>including those related to the infusion site, in healthy adult participants who received a single dose of IVIb and oral placebo administration given concurrently as compared to a crossover oral ibuprofen and intravenous placebo administration. This will be done by frequently asking the volunteer non leading questions regarding there well-being, also visual observation looking for volunteer deteriation.<br>Adevrse Events iexamples: swelling and redness at infusion site, nausea and headache.[Predose, Immediately after<br>completion of the intravenous CTM administration then at Hours 0.5, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours after treatment.]