Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000316404
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 formulation, in healthy volunteers, fasting conditions
Scientific title
Single-centre, randomized, single dose, three-period cross-over open-label dose-normalized pharmacokinetic study of a fixed dose oral combination of acetaminophen and ibuprofen versus acetaminophen oral formulation and ibuprofen oral formulation, in healthy volunteers, fasting conditions
Secondary ID [1] 288710 0
AFT-MX-13A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief 297916 0
Condition category
Condition code
Anaesthesiology 298083 298083 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 three treatments, as oral tablets, in a balanced, three-ways cross-over sequence:
Treatment A: 975 mg acetaminophen + 292,5 mg ibuprofen
Treatment B: 650 mg acetaminophen + 75 mg tramadol hydrochloride
Treatment C: 800 mg ibuprofen
All treatments will be administered as oral tablets with a full glass of water. The administration of the doses will be supervised on site, Participants will be required to fast overnight at least 10 hours before dosing and four hours thereafter, The washout period between periods is 3 days, The dose frequency is single dose. All participants complete all three periods treatment A-C in a cross-over fashion.
Intervention code [1] 294122 0
Treatment: Drugs
Comparator / control treatment
Treatment B: 650 mg acetaminophen + 75 mg tramadol hydrochloride
Treatment C: 800 mg ibuprofen
Both treatments B and C are administered with a full glass of water
Dose frequency: single dose
Control group
Active

Outcomes
Primary outcome [1] 297596 0
To determine and compare dose-normalized acetaminophen and ibuprofen related pharmacokinetic parameters (Cmax, AUC(0-t), AUC(0-inf), Tmax and t1/2 of acetaminophen and ibuprofen
Timepoint [1] 297596 0
Single dose study measuring plasma concentrations measured pre-dose and at 10, 20, 30, 45 minutes and 1, 1.25, 1.50, 2,2.5, 3,4,6,8,10 and 12 hours after the study drug administration.
Secondary outcome [1] 321536 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. At the end of each study period an additional blood sample will be taken for hematology and biochemistry assessment. Known NSAID adverse effects (i.e. gastrointestinal(GI) ulceration, indigestion, stomach pain, GI bleeding, bronchospasm, water retention, renal failure, skin reactions and thromboembolic events). Known acetaminophen adverse events(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] 321536 0
Safety will be evaluated during each study period (from administration to 12 hours post administration) at Days 1, 4, 7 and 14 days following study 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, 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
1/04/2016
Actual
27/03/2016
Date of last participant enrolment
Anticipated
1/06/2016
Actual
8/04/2016
Date of last data collection
Anticipated
Actual
1/06/2016
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 7654 0
Jordan
State/province [1] 7654 0
Amman

Funding & Sponsors
Funding source category [1] 293057 0
Commercial sector/Industry
Name [1] 293057 0
AFT Pharmaceuticals Ltd.
Country [1] 293057 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] 291836 0
None
Name [1] 291836 0
Address [1] 291836 0
Country [1] 291836 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294565 0
International Pharmaceutical Research Centre
Ethics committee address [1] 294565 0
Sport City Circle, Amman,11196 Jordan
1 Queen Rania Street
Ethics committee country [1] 294565 0
Jordan
Date submitted for ethics approval [1] 294565 0
01/03/2016
Approval date [1] 294565 0
15/03/2016
Ethics approval number [1] 294565 0

Summary
Brief summary
This study is designed as a Phase I trial to evaluate the pharmacokinetic profile of different doses of acetaminophen and ibuprofen administered orally to 30 healthy adult volunteers in fasting conditions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41970 0
Dr Isam Salem
Address 41970 0
International Pharmaceutical Research Centre
Sport City Circle, Amman, 11196, Jordan
1 Queen Rania Street
Country 41970 0
Jordan
Phone 41970 0
+96265627648
Fax 41970 0
Email 41970 0
iprc@iprc.com.jo
Contact person for public queries
Name 41971 0
Dr Hartley Atkinson
Address 41971 0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, New Zealand
Country 41971 0
New Zealand
Phone 41971 0
+6494880232
Fax 41971 0
Email 41971 0
hartley@aftpharm.com
Contact person for scientific queries
Name 41972 0
Dr Hartley Atkinson
Address 41972 0
AFT Pharmaceuticals Ltd, Level 1, 129 Hurstmere Rd, Takapuna, 0622, Auckland, New Zealand
Country 41972 0
New Zealand
Phone 41972 0
+6494880232
Fax 41972 0
Email 41972 0
hartley@aftpharm.com

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.