Pharmacokinetic study of acetaminophen and ibuprofen oral formulation, in healthy volunteers, fasting conditions

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000316404
• Date of registration: 10/03/2016
• Prospective Registration: Yes
• Primary sponsor: AFT Pharmaceuticals Ltd.
• 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
• Date of first enrolment: 27/03/2016
• Target sample size: 30
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000316404.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Crossover;Type of endpoint: Pharmacokinetics;
• Phase: Phase 1

Countries of recruitment

Jordan

Contacts

• Name: Dr Hartley Atkinson

• Name: Dr Hartley Atkinson

Key inclusion & exclusion criteria

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.

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.

Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anaesthesiology - Pain management

Pain relief;
Pain relief

Intervention(s)

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.

Primary Outcome(s)

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[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(s)

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[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]

Secondary ID(s)

AFT-MX-13A

Source(s) of Monetary Support

AFT Pharmaceuticals Ltd.

Ethics review

Status: Approved
Approval date:
Contact:

International Pharmaceutical Research Centre