The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov
Ethics application status
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
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Drugs - IVIb
Experimental: 1 -
Active Comparator: 2 -
Treatment: Drugs: 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
Intervention code 
Comparator / control treatment
Primary outcome 
To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
Secondary outcome 
To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.
Key inclusion criteria
- Healthy volunteers between the ages of 18 and 65 years (at the time of consent).
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Participants lacking good venous access in both arms.
- History of allergy or hypersensitivity to NSAIDs or any component of intravenous
- 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
- 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
- Refusal to provide written authorization for use and disclosure of protected health
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Centre for Pharmaceutical Research - Underdale
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
The primary objective of this study is to evaluate the pharmacokinetic profile of a single
dose of IVIb administered over 5-7 minutes.
Trial related presentations / publications
Robert Milne, Associate Professor
Centre for Pharmaceutical Research