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Trial registered on ANZCTR


Registration number
ACTRN12613000887774
Ethics application status
Approved
Date submitted
5/08/2013
Date registered
8/08/2013
Date last updated
28/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploratory Phase 1 pharmacokinetic study of different doses of paracetamol plus ibuprofen under fasting and fed conditions
Scientific title
Single-centre, single-dose, open label, randomized, four-way cross-over study evaluating the pharmacokinetics of paracetamol plus ibuprofen in 28 healthy volunteers under fasting and fed conditions
Secondary ID [1] 282967 0
Nil
Universal Trial Number (UTN)
Trial acronym
AFT-MX-10
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetic study 289791 0
Condition category
Condition code
Other 290145 290145 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
To evaluate the pharmacokinetic parameters of different fixed dose combinations, under fasting conditions as follows:
- paracetamol 325 mg + ibuprofen 97.5 mg -
- paracetamol 650 mg + ibuprofen 195 mg
- paracetamol 975 mg + ibuprofen 292.5 mg

To describe the effect of food on the pharmacokinetic profile of paracetamol 975 mg + ibuprofen 292.5 mg

All drugs are administered orally, as single doses.

To evaluate safety and tolerability of the different doses of paracetamol and ibuprofen under fasting and fed conditions.
There will be a washout period of 7 days from the completion of dosing in one period to the start of the dosing in the next period.
Participants will be fasted for at least 10 hours overnight before dosing and for 4 hours post dosing. Participants will be provided with standard meals from 4 hours post dose.
Drug assays will be carried out using validated chromatographic methods developed specifically for the determination of paracetamol and ibuprofen.

Participants allocated to receive the treatment under fed conditions will receive 30 minutes before the administration of the study drug a standardised high-fat, high-calorie meal. No additional food will be allowed for at least 4 hours after dosing
Intervention code [1] 287676 0
Treatment: Drugs
Comparator / control treatment
The treatment group that receives paracetamol 325 mg + ibuprofen 97.5 mg (3 tablets) under fasting conditions
Control group
Dose comparison

Outcomes
Primary outcome [1] 290171 0
Evaluation of Pharmacokinetic paramaters [Cmax, AUC, Tmax, T 1/2] of different doses of paracetamol and ibuprofen under fasting and fed conditions.

Timepoint [1] 290171 0
Single dose study measuring plasma concentrations over 5, 15, 30, 45 minutes and 1, 1.25, 1.5, 2, 3, 6, 8, 10 and 12 hours after study drug administration
Secondary outcome [1] 304046 0
Safety will be evaluated during each study period, and for 7 days following study drug administration.
An acute safety evaluation will be performed during each study period by recording spontaneously reported adverse events and by clinical assessments, including measurements of blood pressure and heart rate.
At screening and at the end of each study period an additional blood sample will be taken for haematology and biochemistry assessment.
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.
Adverse events will continue to be assessed up to 7 days after the last dose of the study medication by spontaneous reporting and at a final follow-up phone call.
Timepoint [1] 304046 0
Safety will be evaluated during each study period, and for 7 days following study drug administration.

Eligibility
Key inclusion criteria
Healthy volunteers.
Participants must not have taken any prescription medications for at least 14 days or over-the-counter medications for at least 7 days before the start of each study phase, with the exception of oral contraceptives and the study medication.

Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnancy, nursing, drug abuse, smoking > 10 cigarettes per day, excess alcohol intake, Rx drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests, have any history of allergy or hypersensitivity to ibuprofen, aspirin, paracetamol or other NSAID

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
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] 5266 0
Jordan
State/province [1] 5266 0
Amman

Funding & Sponsors
Funding source category [1] 287740 0
Commercial sector/Industry
Name [1] 287740 0
AFT Pharmaceuticals Ltd
Address [1] 287740 0
Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country [1] 287740 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd
Address
Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country
New Zealand
Secondary sponsor category [1] 286467 0
None
Name [1] 286467 0
Address [1] 286467 0
Country [1] 286467 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289694 0
IPRC Institutional Review Board
Ethics committee address [1] 289694 0
172 Queen Rania St
PO Box 963166
Amman 11942
Ethics committee country [1] 289694 0
Jordan
Date submitted for ethics approval [1] 289694 0
26/08/2013
Approval date [1] 289694 0
31/10/2013
Ethics approval number [1] 289694 0

Summary
Brief summary
To determine the pharmacokinetic linearity of a fixed dose combination of paracetamol and ibuprofen (Maxigesic 325) and compare the pharmacokinetic (PK) parameters following fed and fasting administration to provide an estimate of food effect
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41966 0
Prof N. Najib
Address 41966 0
International Pharmaceutical Research Center Queen Rania St - Sport City Circle PO Box 963166 Amman 11196
Country 41966 0
Jordan
Phone 41966 0
+962562764/51
Fax 41966 0
+96265627654
Email 41966 0
iprc@iprc.com.jo
Contact person for public queries
Name 41967 0
Dr Hartley Atkinson
Address 41967 0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country 41967 0
New Zealand
Phone 41967 0
+6494880232
Fax 41967 0
Email 41967 0
hartley@aftpharm.com
Contact person for scientific queries
Name 41968 0
Dr Hartley Atkinson
Address 41968 0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, Auckland 0622
Country 41968 0
New Zealand
Phone 41968 0
+6494880232
Fax 41968 0
Email 41968 0
hartley@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