Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000860864
Ethics application status
Approved
Date submitted
9/08/2012
Date registered
15/08/2012
Date last updated
23/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Maxigesic PE Study: Determining the bioavailaiblity of Maxigesic PE in healthy adult volunteers.
Scientific title
Maxigesic PE Study: Comparative, randomised, single dose, three period, cross-over, open-label study to determine the bioavailability of AFT Pharmaceuticals test product Maxigesic PE relative to reference I Maxigesic and reference II phenylephrine in healthy adult volunteers under fasting conditions.
Secondary ID [1] 280996 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetics of Maxigesic PE in Healthy Volunteers 287128 0
Condition category
Condition code
Other 287448 287448 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 PE as a single oral dose of two tablets (total dose paracetamol 1000mg, ibuprofen 150mg and phenylephrine 10mg).

Cross-over study with 7 day washout period between dosing.

Note: Maxigesic PE is the brand name of this product. Each tablet of Maxigesic PE contains 500mg paracetamol, 150mg ibuprofen and 5mg phenylephrine.
Intervention code [1] 285451 0
Treatment: Drugs
Comparator / control treatment
Comparator 1:
Maxigesic as a single oral dose of two tablets (total dose paracetamol 1000mg and ibuprofen 300mg).
Comparator 2:
Phenylephrine as a single oral dose of two tablets (total dose phenylephrine 10mg).
Control group
Active

Outcomes
Primary outcome [1] 287712 0
To describe the pharmacokinetics of Maxigesic PE and identify whether a pharmacokinetic interaction exists between phenylephrine and paracetamol or ibuprofen when given concomitantly.

This will be assessed by taking blood samples which will be assyed for paracetamol, ibuprofen and phenylephrine concentrations and the pharmacokinetic parameters AUC0-inf, AUC0-t, Cmax, Ke, Tmax and T1/2 will be determined. These pharmacokinetic parameters will be compared between groups.
Timepoint [1] 287712 0
Blood samples will be collected pre-dose and at 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2.0, 3.0, 6.0, 8.0, 10.0 and 12.0 hours after study drug administration.
Secondary outcome [1] 298679 0
To examine the safety and tolerability of Maxigesic PE.

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), known paracetamol adverse effects (i.e. clinical evidence of hepatotoxicity) and known phenylephrine adverse effects (i.e. bradycardia, hypertension) will be compared between groups.
Timepoint [1] 298679 0
Adverse event reporting will be by spontaneous reporting 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 ang 30.0 kg/m2
3) Healty volunteers as determined by medical history, physical examination, ECG, vital signs and laboratory tests
Minimum age
18 Years
Maximum age
50 Years
Sex
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, paracetamol or phenylephrine
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
20/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 4467 0
Jordan
State/province [1] 4467 0
Amman

Funding & Sponsors
Funding source category [1] 285784 0
Commercial sector/Industry
Name [1] 285784 0
AFT Pharmaceuticals Ltd
Country [1] 285784 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd
Address
Level 1,
Nielsen Building,
129 Hurstmere Road,
Takapuna
Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 284607 0
None
Name [1] 284607 0
Address [1] 284607 0
Country [1] 284607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287792 0
Jordan Food and Drug Administration
Ethics committee address [1] 287792 0
Ethics committee country [1] 287792 0
Jordan
Date submitted for ethics approval [1] 287792 0
Approval date [1] 287792 0
07/06/2012
Ethics approval number [1] 287792 0
2/4/34/20003

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

Contacts
Principal investigator
Name 34555 0
Address 34555 0
Country 34555 0
Phone 34555 0
Fax 34555 0
Email 34555 0
Contact person for public queries
Name 17802 0
Amanda Potts
Address 17802 0
Level 1,
Nielsen Building,
129 Hurstmere Road,
Takapuna
Auckland 0622
Country 17802 0
New Zealand
Phone 17802 0
+64 9 488 0232
Fax 17802 0
Email 17802 0
[email protected]
Contact person for scientific queries
Name 8730 0
Amanda Potts
Address 8730 0
Level 1,
Nielsen Building,
129 Hurstmere Road,
Takapuna
Auckland 0622
Country 8730 0
New Zealand
Phone 8730 0
+64 9 488 0232
Fax 8730 0
Email 8730 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.