ACTRN12621001542886已完成1 期
Randomized, Single Dose, Three-Way Crossover Open Label Study To Evaluate The Pharmacokinetic Parameters Of 1000 mg Acetaminophen, 300 mg Ibuprofen And 50 mg Diphenhydramine Hydrochloride, After An Administration To 30 Healthy Adults Under Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
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 are met:
- •Male or female subjects 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 18.5 and 30.0 kg/m2.
- •Have no significant disease (asthma, peptic or gastric ulcer, sinusitis, pharyngitis, gastrointestinal disease, pulmonary disease, renal disorder (impaired renal function), hepatic disorder (impaired hepatic function), cardiovascular disorder, neurological disease such as epilepsy, haematological disorders or diabetes, psychiatric, infective, dermatologic or immunological disorders) as determined by medical history, physical examination and laboratory tests.
- •Have negative HIV and hepatitis B & C test results.
- •Be able and willing to abstain from caffeine-containing beverages (e.g. coffee, soda, energy drinks or tea), caffeine-containing food (e.g. chocolate), and alcohol for at least 24 hours prior to study drug administration until the last study sample is collected in each period.
- •Be able and willing to abstain from any food or beverages containing grapefruit for at least 7 days prior to study drug administration until the last study sample is collected in each period.
- •Be able and willing to abstain from prescription drugs (not including oral contraceptives and the study medication) within at least 14 days or over-the-counter drugs within at least 7 days before the start of each study phase and during the study.
- •Be able and willing to abstain from vitamins taken for nutritional purposes for at least 2 days prior to study drug administration until the last study sample is collected in each period.
- •Be able and willing to abstain from smoking throughout the whole duration of the study.
- •Have a medically acceptable normal 12-lead ECG (No QTc Prolongation).
排除标准
- •Participants will not be eligible for inclusion in this study if any of the following criteria are met:
- •Study contra-indications:
- •Female who is pregnant or nursing (not applicable for male subjects).
- •Female of childbearing potential who is 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 (not applicable for male subjects).
- •Female of childbearing potential who is unwilling to undergo a urine pregnancy test (not applicable for male subjects).
- •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 drugs of abuse during screening.
- •Have a history of allergic reactions to acetaminophen, ibuprofen and diphenhydramine hydrochloride
- •Unwilling to abstain from smoking throughout the whole duration of the study
- •Unable and refuse to abstain the use of prescription drugs (not including oral contraceptives and the study medication) within at least 14 days or over-the-counter drugs within at least 7 days before the start of each study phase and during the study.
- •Unable and refuse to abstain the use of vitamins for nutritional purposes within at least
- •2 days prior to study drug administration until the last study sample is collected in each period.
- •Unable and refuse to abstain to consume grapefruit containing foods or beverages within at least 7 days or caffeine containing foods or beverages within at least 24 hours prior to study drug administration until the last study sample is collected in each period.
- •Currently, or in last 80 days, participating in a clinical trial involving another study drug.
- •Have donated blood or blood products within 60 days prior to study drug administration.
- •Have any clinically significant results from laboratory tests, however, ALP, urea and creatinine will be accepted if below reference range, total protein and albumin will be accepted if above reference range after being evaluated by the physician as clinically not significant. Haematology tests with deviation of more than 5% of the reference limits. Laboratory tests are performed not longer than two weeks before the initiation of the clinical study.
- •Be on a special diet (for example is vegetarian).
- •Unable and refuse to abstain from engaging in strenuous exercise within at least 24 hours prior to study drug administration until the last sample is collected in each study period.
- •Have at screening examination a pulse outside the normal range of (60-100 beat per minute) or a body temperature outside the normal range of (35.0-37.2 C) or a respiratory rate outside the normal range of (14-20 breath per minute) or a sitting blood pressure less than 100/60 mm Hg or more than or equal to 140/90 mm Hg.
- •Unable and refuse to abstain from consuming any beverages or food containing alcohol for at least 24 hours prior to study drug administration until the last study sample is collected in each period.
- •Have a history of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption.
- •Suffering from any other diseases or condition which, in the opinion of the invest
研究者
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