HealthyPhase 1NCT00867880
Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects
A Phase 1 study testing IVIb in people with Healthy, run by Cumberland Pharmaceuticals at 1 site in Australia.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IVIb
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2009to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers between the ages of 18 and 65 years (at the time of consent).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Centre for Pharmaceutical Research
Underdale, South Australia, 5032
About this study
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
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
- Conditions
- Healthy
- Being tested
- IVIb
- Keywords
- To evaluate the Pharmacokinetic Profile of IVIb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIbDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: IVIb |
| 2 | Active comparator | Not described Receives: Drug: IVIb |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
Measured: 12 hours
Secondary outcomes (1)
To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Milne, Associate Professor, Principal investigator, Centre for Pharmaceutical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867880
- Sponsor's protocol ID
- CPI-CL-011
- Status last verified
- Dec 2014
- First submitted
- 23 Mar 2009
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00867880
- Acronym / sponsor ID
- CPI-CL-011
- Conditions
- Healthy
- Keywords
- To evaluate the Pharmacokinetic Profile of IVIb
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 24 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IVIb |
| 2 | Active comparator | Drug: IVIb |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers between the ages of 18 and 65 years (at the time of consent).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIb800mg 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 | Drug | 1, 2 |
Primary outcome
To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.
Time frame: 12 hours
1 secondary outcome
To evaluate the safety and tolerability of a single dose of IVIb in healthy adult participants.
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Milne, Associate Professor principal investigator
Centre for Pharmaceutical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IVIb in people with Healthy, run by Cumberland Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes. (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2014.