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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00867880




Registration number
NCT00867880
Ethics application status
Date submitted
23/03/2009
Date registered
24/03/2009
Date last updated
15/12/2014

Titles & IDs
Public title
Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects
Scientific 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
Secondary ID [1] 0 0
CPI-CL-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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 [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
Timepoint [1] 0 0
12 hours
Secondary outcome [1] 0 0
To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.
Timepoint [1] 0 0
12 hours

Eligibility
Key inclusion criteria
- Healthy volunteers between the ages of 18 and 65 years (at the time of consent).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2009
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Centre for Pharmaceutical Research - Underdale
Recruitment postcode(s) [1] 0 0
5032 - Underdale

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cumberland Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00867880
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Milne, Associate Professor
Address 0 0
Centre for Pharmaceutical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00867880