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Trial registered on ANZCTR


Registration number
ACTRN12614000809639
Ethics application status
Approved
Date submitted
24/07/2014
Date registered
30/07/2014
Date last updated
17/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetic study of paracetamol and ibuprofen, solution for infusion, in healthy volunteers
Scientific title
Single-centre, single-dose, open-label, randomised, five-way cross-over study to evaluate the pharmacokinetic parameters of intravenously administered combination of paracetamol and ibuprofen, intravenous paracetamol, intravenous ibuprofen and fixed dose combination tablets of paracetamol and ibuprofen, in healthy volunteers.
Secondary ID [1] 285046 0
NIL
Universal Trial Number (UTN)
Trial acronym
AFT-MXIV-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief 292564 0
Condition category
Condition code
Other 292871 292871 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
Each participant will be randomly allocated to receive a single dose of each of the following five treatments in a balanced five-way crossover sequence:
Treatment A: Intravenous administration of paracetamol 1000 mg + ibuprofen 300 mg/100mL infusion - as a 15 minutes infusion
Treatment B: Intravenous paracetamol 1000 mg/100mL infusion - as a15 minutes infusion
Treatment C: Intravenous ibuprofen 300 mg/100mL infusion- as a15 minutes infusion
Treatment D: Intravenous paracetamol 500 mg + ibuprofen 150 mg/100 ml infusion - as 15 minutes infusion
Treatment E: Two tablets of a fixed dose combination product containing paracetamol 500 mg + ibuprofen 150 mg/tablet -oral administration with a full glass of water
Washout period between treatments - 7 days
Dose frequency - single dose
All participants complete all five periods (treatments A-E) in a cross-over fashion.
Intervention code [1] 289882 0
Treatment: Drugs
Comparator / control treatment
Treatment B: Intravenous paracetamol 1000 mg/100mL infusion - as a15 minutes infusion
Treatment C: Intravenous ibuprofen 300 mg/100mL infusion- as a15 minutes infusion
Treatment E: Two tablets of a fixed dose combination product containing paracetamol 500 mg + ibuprofen 150 mg/tablet -oral administration with a full glass of water
Dose frequency: single dose
Control group
Active

Outcomes
Primary outcome [1] 292745 0
Evaluation of pharmacokinetic parameters (Cmax, AUC(0-t), AUC(0-8), Tmax and t1/2) of paracetamol and ibuprofen
Timepoint [1] 292745 0
Single dose study measuring plasma concentrations measured at the completion of the intravenous infusion at 5, 10, 15, 20, 30,45 minutes and at 1, 1.25, 1.5, 2,3,4,6,8,10 and 12 hours.
Secondary outcome [1] 309592 0
Safety will be evaluated during each study period, and for 7 days following last dose of study drug administration.
An acute safety evaluation will be performed during each study period by recording spontaneously reported AEs and by clinical assessments.
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), known paracetamol adverse effects (i.e. clinical evidence of hepatotoxicity) and known IV administration adverse effects (pain at injection site) will be summarized by treatment groups)
Adverse events will continue to be assessed up to 7 days after the last dose of the study medication by spontaneous reporting and a final follow-up call.
Timepoint [1] 309592 0
Single dose study measuring plasma concentrations over 5, 10, 15, 20, 45 minutes and at 1, 1.25, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours.
Safety will be evaluated during each study period and for 7 days following study administration

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
50 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, prescription drugs within 14 days of the study, participating in another trial within 80 days, clinically significant abnormal lab tests.

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
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] 6248 0
New Zealand
State/province [1] 6248 0
Christchurch

Funding & Sponsors
Funding source category [1] 289657 0
Commercial sector/Industry
Name [1] 289657 0
AFT Pharmaceuticals Ltd.
Address [1] 289657 0
Level 1, 129 Hurstmere Rd, Takapuna, Auckland, 0622, New Zealand
Country [1] 289657 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd.
Address
Level 1, 129 Hurstmere Rd, Takapuna, Auckland, 0622, New Zealand
Country
New Zealand
Secondary sponsor category [1] 288347 0
None
Name [1] 288347 0
Address [1] 288347 0
Country [1] 288347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291393 0
Health and Disability Ethics Committee
Ethics committee address [1] 291393 0
No.1 The Terrace
P.0.Box 5013
Wellington
6011
Ethics committee country [1] 291393 0
New Zealand
Date submitted for ethics approval [1] 291393 0
14/08/2014
Approval date [1] 291393 0
25/08/2014
Ethics approval number [1] 291393 0

Summary
Brief summary
To measure the pharmacokinetics (how the body treat drugs) of paracetamol and ibuprofen that are administered intravenously and determine the relative bioavailability of the tablets combination versus that of the intravenous solution
Trial website
Trial related presentations / publications
Manuscript is under preparation.
Public notes

Contacts
Principal investigator
Name 37874 0
Dr Richard Robson
Address 37874 0
Christchurch Clinical Studies Trust Ltd.
31 Tuam Street, PO Box 2856, CHCH 8011
Country 37874 0
New Zealand
Phone 37874 0
+64 3 372 9477
Fax 37874 0
+64 3 372 9478
Email 37874 0
richard@ccst.co.nz
Contact person for public queries
Name 37875 0
Dr Hartley Atkinson
Address 37875 0
AFT Pharmaceuticals Ltd., Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland
Country 37875 0
New Zealand
Phone 37875 0
+ 6494880232
Fax 37875 0
+ 6494880234
Email 37875 0
hartley@aftpharm.com
Contact person for scientific queries
Name 37876 0
Dr Hartley Atkinson
Address 37876 0
AFT Pharmaceuticals Ltd., Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland
Country 37876 0
New Zealand
Phone 37876 0
+ 6494880232
Fax 37876 0
+ 6494880234
Email 37876 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