Pharmacokinetic study of acetaminophen and ibuprofen, solution for infusion and the oral tablet of acetaminophen and ibuprofen in healthy volunteers
Single-centre, single-dose, open-label, randomised, four-way cross-over study to evaluate and compare the pharmacokinetic parameters of a fixed dose combination of intravenous acetaminophen + intravenous ibuprofen, intravenous acetaminophen, intravenous ibuprofen and a fixed dose combination tablet of acetaminophen 325mg + ibuprofen 97.5mg, in healthy volunteers.
AFT Pharmaceuticals Ltd.
30 participants
Apr 10, 2016
Interventional
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 medications for at least 14 days before the start of each study phase, with the exception of oral contraceptives.
- All volunteers 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 Criteria17
- Women who are pregnant or nursing.
- Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral oophorectomy.
- Women of childbearing potential who are unwilling to undergo a urine pregnancy test.
- Have an alcohol intake in excess of 14 units per week for females and 21 units per week for males.
- Have a history of drug abuse or positive test results for drug abuse.
- Is a current smoker.
- Have used prescription drugs (not including oral contraceptives) within 14 days prior to study drug administration or have used over-the-counter drugs herbal products or vitamins within 7 days prior to study drug administration, unless the Principal Investigator and Sponsor agree that the product taken will not impact on study conduct, results or participant safety.
- Currently, or in last 30 days, participating in a clinical trial involving another study drug
- Have donated blood or blood products within 30 days prior to study drug administration
- Have a clinically significant abnormal laboratory test (as determined by the Principle Investigator)
- Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the participant’s best interests to participate in this study
- Have any history of allergy or hypersensitivity to ibuprofen, aspirin or other NSAID
- Have any history of allergy or hypersensitivity to acetaminophen
- Have severe known haemopoetic, renal or hepatic disease, immunosuppression
- Have a history of gastric ulceration, indigestion, stomach pain or GI bleeding or bleeding disorders
- Currently suffering from dehydration through diarrhoea and/or vomiting
- Have a history of severe asthma defined as previous steroid treatment or hospital admission within the last 5 years
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Interventions
Each participant will be randomly allocated to receive a single dose of each of the following four treatments in a balanced four-way crossover sequence Treatment A: intravenous acetaminophen 1000 mg + ibuprofen 300 mg in 100mL infusion Treatment B: intravenous acetaminophen 1000 mg in 100mL infusion Treatment C: intravenous ibuprofen 400 mg in 4 ml infusion Treatment D: Oral acetaminophen 325 mg + ibuprofen 97.5 mg tablet, 3 tablets Washout period between treatments - 7 days Dose frequency - single dose All participants complete all four periods (treatments A-D) in a cross-over fashion.
Locations(1)
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ACTRN12615001208594