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Trial registered on ANZCTR


Registration number
ACTRN12612000871842
Ethics application status
Approved
Date submitted
15/08/2012
Date registered
17/08/2012
Date last updated
23/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Maxigesic Metabolism Study: To describe the metabolism of paracetamol when combined with ibuprofen in healthy adult volunteers.
Scientific title
Single-centre, single-dose, open-label, randomised, cross-over study of the effect of ibuprofen on the oxidative metabolism of paracetamol when administered as a fixed dose combination (Maxigesic) in healthy volunteers under fasting conditions.
Secondary ID [1] 281033 0
Nil
Secondary ID [2] 281050 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics of Maxigesic in Healthy Volunteers. 287169 0
Condition category
Condition code
Other 287495 287495 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
Maxigesic as a single oral dose of two tablets (total dose paracetamol 1000mg and ibuprofen 300mg).

Cross-over study with a 7 day washout period between doses.

Participants will be fasted for at least 10 hours overnight before the administration of the study drug. Standardised meals will be provided from 4 hours after study drug administration. Drinking water will be restricted for 1 hour before and after drug administration (not including the standardised 240mL of water given with the study drug.
Intervention code [1] 285494 0
Treatment: Drugs
Comparator / control treatment
Comparator: Panadol as a single oral dose of two tablets (total dose paracetamol 1000mg).
Control group
Active

Outcomes
Primary outcome [1] 287753 0
To describe the amount of paracetamol and its metabolites excreted in the urine after a single dose of paracetamol alone or in combination with ibuprofen (Maxigesic).

This will be assessed by measuring the total amount of paracetamol and its metabolites excreted in the urine over 24 hours and the 24 hour extretion rate of paracetamol and its metabolites.
Timepoint [1] 287753 0
Urine will be collected over the study period (24 hours after dosing).
Secondary outcome [1] 298771 0
To examine the safety and tolerability of Maxigesic.

Safety will be evaluated during each study period, and for 7 days following study drug administration. Acute safety evaluations will be performed during each study period by recording spontaneously reported AE's and by clinical assessments (incl. heamatology & biochemistry).

Known NSAID adverse effects (i.e. GI ulceration, indigestion/stomach pain, GI bleeding, bronchospasm, water retention, renal failure, skin reactions and thromboembolic events) and known paracetamol adverse effects (i.e. clinical evidence of hepatotoxicity) will be compared between groups.
Timepoint [1] 298771 0
Adverse event reporting will be by spontaneous reproting up to 7 days after dosing, and by a follow up phone call 7 days after the last dose of the study medication.

Eligibility
Key inclusion criteria
1) Provide written informed consent
2) Have Body Mass Index between 18.5 and 30.0 kg/m2
3) Healthy volunteers as determined by medical history, physical examination, ECG, vital signs and laboratory tests
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Women who are pregnant or nursing
2) Women who are unwilling to take adequate contraceptive precaustions or who are unwilling to undergo urine pregnancy testing
3) History of alcohol or drug abuse or dependency
4) Have a history of allergy or hypersensitivity to ibuprofen, aspirin, any other NSAID or paracetamol
5) Have haemopoetic, renal or hepatic disease, immunosupression. Have a history of gastric ulceration, indigestion, stomach pain, GI bleeding or bleeding disorders. Are currently suffering from dehydration from diarrhoea and/or vomiting. Have a history of severe asthma. Have a history of severe hypertension, ventricular tachycardia or other cardiac disease. Have insulin dependent diabetes mellitus.

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 will occur once participant eligability is confirmed. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4486 0
Jordan
State/province [1] 4486 0

Funding & Sponsors
Funding source category [1] 285820 0
Commercial sector/Industry
Name [1] 285820 0
AFT Pharmaceuticals Ltd
Address [1] 285820 0
Level 1,
Nielsen Building,
129 Hurstmere Road,
Takapuna
Auckland 0622
Country [1] 285820 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmacetuicals Ltd
Address
Level 1,
Nielsen Building,
129 Hurstmere Road,
Takapuna
Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 284644 0
None
Name [1] 284644 0
Address [1] 284644 0
Country [1] 284644 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287835 0
Jordan Food and Drug Administration
Ethics committee address [1] 287835 0
P O Box 811951
Amman
Ethics committee country [1] 287835 0
Jordan
Date submitted for ethics approval [1] 287835 0
07/08/2012
Approval date [1] 287835 0
Ethics approval number [1] 287835 0

Summary
Brief summary
This study is designed to assess if ibuprofen changes the metabolic profile of paracetamol when given as a fixed dose combination.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34581 0
Address 34581 0
Country 34581 0
Phone 34581 0
Fax 34581 0
Email 34581 0
Contact person for public queries
Name 17828 0
Amanda Potts
Address 17828 0
Level 1,
Nielsen Building,
129 Hurstmere Road,
Takapuna
Auckland 0622
Country 17828 0
New Zealand
Phone 17828 0
+64 9 488 0232
Fax 17828 0
Email 17828 0
amanda@aftpharm.com
Contact person for scientific queries
Name 8756 0
Amanda Potts
Address 8756 0
Level 1,
Nielsen Building,
129 Hurstmere Road,
Takapuna
Auckland 0622
Country 8756 0
New Zealand
Phone 8756 0
+64 9 488 0232
Fax 8756 0
Email 8756 0
amanda@aftpharm.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary