A Pharmacokinetic study evaluating the pharmacokinetic parameters of different doses of Maxigesic® IV (intravenous paracetamol + intravenous ibuprofen) in healthy Japanese volunteers and Caucasian volunteers
Maxigesic IV PK Study: Single-centre, randomised, open label, single dose study to evaluate the pharmacokinetic parameters of different doses of Maxigesic® IV (intravenous paracetamol + intravenous ibuprofen) in healthy Japanese volunteers and Caucasian volunteers
AFT Pharmaceuticals Ltd
24 participants
Apr 4, 2024
Interventional
Conditions
Summary
This study is designed as a pharmacokinetic study to describe the pharmacokinetics of Maxigesic® IV in healthy Japanese subjects and compare them versus those of Caucasian subjects. Additionally, to determine whether the dose proportionality is observed from the comparison of two different doses of Maxigesic IV (Mid and High). This study will include 24 healthy volunteers (12 healthy Japanese volunteers and 12 healthy Caucasian volunteers).
Eligibility
Inclusion Criteria12
- A participant will be eligible for inclusion in this study only if all of the following criteria
- are met:
- Male and female volunteers aged between 18 and 50 years, inclusive, on the day of consent.
- Voluntarily provide written informed consent before the initiation of any study related
- procedures.
- Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m2.
- Have a body weight of at least 50 kg
- Have no significant disease (cardiac, pulmonary, GI, hepatic, renal, haematological, neurological, infective, or psychiatric) as determined by medical history, physical examination and laboratory tests as determined by the Principal Investigator.
- Have negative HIV and hepatitis B & C test results.
- Be able and willing to abstain from caffeine-containing beverages (e.g. coffee, soda, or tea), caffeine-containing food (e.g. chocolate), and alcohol for 24 hours prior to study drug administration until after the last study sample is collected in each dosing period.
- Be able and willing to abstain from all prescription and over-the-counter medications (excluding the study drug and oral contraceptive) and herbal remedies for the duration of the study as determined by the Principal Investigator.
- Have a normal 12-lead ECG or one with an abnormality considered to be clinically insignificant as determined by the Principal Investigator.
Exclusion Criteria19
- Participants will not be eligible for inclusion in this study if any of the following criteria
- are met:
- 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 Principal 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 paracetamol
- 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
Participants will be randomly assigned to one of the two possible study drug treatment sequences in a fashion that ensures each individual receives each treatment, that for each study period at least 24 participants (12 Japanese and 12 Caucasian) are allocated to each treatment and that the first-order carry-over effects are minimised. Treatment A: 100 mL of Maxigesic® IV (paracetamol 1000 mg + intravenous ibuprofen 300 mg in 100mL infusion) = Maxigesic IV HIGH dose (1000 mg paracetamol + 300 mg ibuprofen) Each intravenous study formulation will be administered as a single, intravenous dose, infused over 15 minutes into an intravenous cannula. The administration of each dose will be documented in the Case Report Form (CRF) by a study nurse. Washout period between treatments - at least 48 hours All participants complete both periods (treatments A and B) in a cross-over fashion.
Locations(1)
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ACTRN12624000087550