Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000317493
Ethics application status
Approved
Date submitted
7/03/2016
Date registered
10/03/2016
Date last updated
3/03/2017
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
AFT-MX-13B
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

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 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
Active

Outcomes
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.

Eligibility
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
Sex
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 laboratory 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
1/04/2016
Actual
27/03/2016
Date of last participant enrolment
Anticipated
Actual
8/04/2016
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7655 0
Jordan
State/province [1] 7655 0
Amman

Funding & Sponsors
Funding source category [1] 293061 0
Commercial sector/Industry
Name [1] 293061 0
AFT Pharmaceuticals Ltd.
Country [1] 293061 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd.
Address
Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 291840 0
None
Name [1] 291840 0
Address [1] 291840 0
Country [1] 291840 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294570 0
International Pharmaceutical Research Centre
Ethics committee address [1] 294570 0
Ethics committee country [1] 294570 0
Jordan
Date submitted for ethics approval [1] 294570 0
01/03/2016
Approval date [1] 294570 0
15/03/2016
Ethics approval number [1] 294570 0

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

Contacts
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
Jordan
Phone 64198 0
+96265627648
Fax 64198 0
Email 64198 0
[email protected]
Contact person for public queries
Name 64199 0
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
+6494880232
Fax 64199 0
Email 64199 0
[email protected]
Contact person for scientific queries
Name 64200 0
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
+6494880232
Fax 64200 0
Email 64200 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.