ACTRN12624000087550招募中1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
入选标准
- •A participant will be eligible for inclusion in this study only if all of the following criteria
- •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.
排除标准
- •Participants will not be eligible for inclusion in this study if any of the following criteria
- •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
研究者
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