Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000474257
Ethics application status
Approved
Date submitted
26/05/2009
Date registered
17/06/2009
Date last updated
7/04/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the uptake into, and removal from the human body, of meloxicam when taken in two different forms of the medication: a new formulation of meloxicam, Meloxicam Nanoformulation capsules; and marketed capsules (known as Mobic (Registered trademark(R)), when taken after a fast and after a high fat breakfast.
Scientific title
Single-Dose, four-way crossover, relative bioavailability study of Meloxicam Nanoformulation 7.5 mg Capsules and Mobic (Registered Trademark (R)) 7.5 mg Capsules in Healthy subjects under Fed and Fasted Condition
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammation 4860 0
Condition category
Condition code
Inflammatory and Immune System 237209 237209 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Meloxicam Nanoformulation, 7.5 mg Capsule, single dose, oral, taken after minimum 10 hr fast
Arm 2: Mobic 7.5 mg Capsule, single dose, oral, taken after minimum 10 hr fast
Arm 3: Meloxicam Nanoformulation, 7.5 mg Capsule, single dose, oral, taken 30 mins after high fat breakfast
Arm 4: Mobic 7.5 mg Capsule, single dose, oral, taken 30 mins after high fat breakfast

Washout period between treatment arms is 7 days. Each subject will undergo all 4 treatment arms.
Intervention code [1] 236642 0
Treatment: Drugs
Comparator / control treatment
Mobic (Registered Trademark (R)) (Meloxicam), 7.5 mg capsules, single dose, oral
Control group
Active

Outcomes
Primary outcome [1] 238020 0
Rate of Absorption

This will be assessed by blood analysis.
Timepoint [1] 238020 0
0, 10, 20, 30, 45 mins, 1 hr, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours
Primary outcome [2] 238021 0
Extent of Absorption

This will be assessed by blood analysis.
Timepoint [2] 238021 0
0, 10, 20, 30, 45 mins, 1 hr, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours
Secondary outcome [1] 242165 0
Effect of food on rate of absorption

This will be assessed by blood analysis.
Timepoint [1] 242165 0
0, 10, 20, 30, 45 mins, 1 hr, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours
Secondary outcome [2] 242166 0
Effect of food on extent of absorption

This will be assessed by blood analysis.
Timepoint [2] 242166 0
0, 10, 20, 30, 45 mins, 1 hr, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours

Eligibility
Key inclusion criteria
Available for entire study period.
Body mass index (BMI) between 18 kg/m2 and 30 kg/m2 and weighing at least 50 kg.
In good general health.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of hypersensitivity to naproxen, aspirin or related compounds.
History of gastrointestinal ulcers or bleeding.
History of surgery of the digestive tract (except for appendectomy).
Presence of any conditions that affect the absorption, metabolism or passage of drugs out of the body (e.g. sprue, coeliac disease, Crohn's disease, colitis, liver or kidney conditions).
Recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism.
Use of any drugs known to induce of inhibit hepatic drug metabolism within 30 days of planned dosing.
If femals, lactating, or positive pregnancy test at screening, or prior to each of the treatment periods.

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)
Randomisation numbers will be allocated sequentially as subjects are enrolled.
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects meeting the eligibility criteria will be randomised to one of the 2 sequences of treatment administration.
The methods used is by using a randomisation table created by a computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5024 0
Commercial sector/Industry
Name [1] 5024 0
iCeutica Pty ltd
Country [1] 5024 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
iCeutica Pty Ltd
Address
52 Fairfield Street
Mt Hawthorn WA 6016
Country
Australia
Secondary sponsor category [1] 4543 0
None
Name [1] 4543 0
Address [1] 4543 0
Country [1] 4543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239122 0
Queensland Institute of Medical Research (QIMR) Human Research Ethics Committee (HREC)
Ethics committee address [1] 239122 0
Ethics committee country [1] 239122 0
Australia
Date submitted for ethics approval [1] 239122 0
16/03/2009
Approval date [1] 239122 0
17/04/2009
Ethics approval number [1] 239122 0
P1245

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29652 0
Address 29652 0
Country 29652 0
Phone 29652 0
Fax 29652 0
Email 29652 0
Contact person for public queries
Name 12899 0
Ms Susan Heggie
Address 12899 0
QPharm Pty Ltd
Level D, Clive Berghofer Cancer Research Centre (CBCRC) Building
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4006
Country 12899 0
Australia
Phone 12899 0
+61 7 3845 3636
Fax 12899 0
+61 7 3845 3630
Email 12899 0
[email protected]
Contact person for scientific queries
Name 3827 0
Dr Joanne Marjason
Address 3827 0
QPharm Pty Ltd
Level D, CBCRC Building
Queensland Institute of Medical Research
300 Herston Road
Herston QLD 4006
Country 3827 0
Australia
Phone 3827 0
+61 7 3845 3647
Fax 3827 0
+61 7 3845 3630
Email 3827 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.