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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetic study of acetaminophen and ibuprofen, oral formulations, in healthy volunteers under fed conditions
Scientific title
Single-centre, single-dose, open-label, randomised, three-period cross-over study to evaluate the pharmacokinetic parameters of acetaminophen and ibuprofen fixed dose oral combinations, acetaminophen with tramadol hydrochloride, fixed dose oral combination and ibuprofen oral formulation in healthy volunteers, under fed conditions.
Secondary ID [1] 288709 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief 297925 0
Condition category
Condition code
Anaesthesiology 298087 298087 0 0
Pain management

Study type
Description of intervention(s) / exposure
Each participant will be randomly allocated to receive a single dose of each of the following treatments in a balanced three-way cross-over sequence:
Treatment A: 975 mg acetaminophen and 292.5 mg ibuprofen
Treatment B: 650 mg acetaminophen and 75 mg tramadol hydrochloride
Treatment C: 800 mg ibuprofen.
All treatments will be administered as oral tablets, with a full glass of water, in fed conditions. The administration of all doses will be supervised on site. The washout period between the periods is 3 days.
Dose frequency - single dose, administered as oral tablets.
All participants complete all three periods (treatments A-C) in a cross-over fashion.
Participants will be fasted for at least 10 hours overnight before dosing and receive a standardized breakfast served 30 minutes prior to study drug administration. This breakfast will supply around 967kcal about 50% of which are fat calories. A standardized meal will be provided approximately at 5 hours after dosing. Also a snack will be provided approximately at 9 hours after the study drug administration. Meal plans will be identical in all periods and will be served at the same time. Water will be restricted for 1 hour pre-dose and 1 hour post-dose.
Intervention code [1] 294127 0
Treatment: Drugs
Comparator / control treatment
Treatment B: 650 mg acetaminophen and 75 mg tramadol hydrochloride
Treatment C: 800 mg ibuprofen.
All treatments will be administered with a full glass of water, in fed conditions.
Dose frequency: single dose
Control group

Primary outcome [1] 297600 0
To determine and compare dose-normalized acetaminophen and ibuprofen related pharmacokinetic parameters (Cmax,AUC(0-t), AUC(0-inf), Tmax, t1/2)betweeen all treatment groups, under fed conditions
Timepoint [1] 297600 0
Single dose study measuring plasma concentration pre-dose and at 10, 20,30,45 minutes and at 1,1.25,1.50,2,2.5,3,4,6,8,10 and 12 hours after study drug administration.
Secondary outcome [1] 321555 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 adverse events and by clinical assessments.
Known NSAID adverse events (i.e gastrointestinal ulceration, indigestion, stomach pain, GI bleeding, bronchospasm, water retention, renal failure, skin reactions and thromboembolic events)and known acetaminophen adverse effects (i.e.clinical evidence of hepatotoxicity) 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] 321555 0
Safety will be evaluated during each study period (from administration to 12 hours post administration) at Days 1, 4, 6 and for 7 days following study drug administration.

Key inclusion criteria
Healthy volunteers, males and females aged 18 to 50 years of age. Females must be sterile or using adequate contraception. 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.
All subjects must be deemed healthy on the basis of a medical history, physical exam (including vital signs and ECG recording), urinalysis, and blood biochemical and haematological examinations.
Minimum age
18 Years
Maximum age
50 Years
Both males and females
Can healthy volunteers participate?
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 laboratory tests

Study design
Purpose of the study
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
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 7655 0
State/province [1] 7655 0

Funding & Sponsors
Funding source category [1] 293061 0
Commercial sector/Industry
Name [1] 293061 0
AFT Pharmaceuticals Ltd.
Address [1] 293061 0
Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, New Zealand
Country [1] 293061 0
New Zealand
Primary sponsor type
Commercial sector/Industry
AFT Pharmaceuticals Ltd.
Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, New Zealand
New Zealand
Secondary sponsor category [1] 291840 0
Name [1] 291840 0
Address [1] 291840 0
Country [1] 291840 0

Ethics approval
Ethics application status
Ethics committee name [1] 294570 0
International Pharmaceutical Research Centre
Ethics committee address [1] 294570 0
Sport City Circle, 11196, Amman, Jordan
1 Queen Rania Street
Ethics committee country [1] 294570 0
Date submitted for ethics approval [1] 294570 0
Approval date [1] 294570 0
Ethics approval number [1] 294570 0

Brief summary
This study is designed as a Phase 1 trial to evaluate the pharmacokinetic profile of different doses of acetaminophen and ibuprofen administered orally to 30 healthy volunteers and evaluate the effect of food on the pharmacokinetic profile
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 64198 0
Dr Isam Salem
Address 64198 0
International Pharmaceutical Research Center, Jordan
Sport City Circle, Amman 11196, Jordan
1 Queen Rania Street
Country 64198 0
Phone 64198 0
Fax 64198 0
Email 64198 0
Contact person for public queries
Name 64199 0
Dr Hartley Atkinson
Address 64199 0
AFT Pharmaceuticals Ltd. Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, NZ
Country 64199 0
New Zealand
Phone 64199 0
Fax 64199 0
Email 64199 0
Contact person for scientific queries
Name 64200 0
Dr Hartley Atkinson
Address 64200 0
AFT Pharmaceuticals Ltd.
Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, NZ
Country 64200 0
New Zealand
Phone 64200 0
Fax 64200 0
Email 64200 0

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