Clinical trial NCT00867880: Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Dose, Crossover Study of the Pharmacokinetics, Safety and Tolerability of Ibuprofen Inejction (IVIb) In Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: To evaluate the Pharmacokinetic Profile of IVIb
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
timeFrame: 12 hours
Secondary outcomes:
measure: To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.
timeFrame: 12 hours
Other outcomes:
Locations:
city: Underdale
country: Australia
facility: Centre for Pharmaceutical Research
state: South Australia
Study officials:
affiliation: Centre for Pharmaceutical Research
name: Robert Milne, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References: