A single dose, four-way, open-label study to determine the pharmacokinetics and bioavailability of an oral suspension of combined acetaminophen and ibuprofen, a powder sachet of combined acetaminophen and ibuprofen for oral solution and two tablet formulations of combined acetaminophen and ibuprofen in 28 healthy volunteers under fed conditions.

AFT Pharmaceuticals Ltd0 个研究点目标入组 28 人开始时间: 2016年4月1日最近更新: 2020年1月13日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: AFT Pharmaceuticals Ltd
入组人数: 28

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

The study confirmed that the maximum blood level and the time profile of the drugs in the body of four different formulations (oral suspension, oral sachet, oral tablet of acetaminophen 500mg + ibuprofen 150mg and oral tablet of acetaminophen 325mg + ibuprofen 97.5mg) of a fixed dose combination containing acetaminophen and ibuprofen are all similar in healthy adults under fed conditions. All these four different formulations are well tolerated.

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

•Healthy subjects, 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 3 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 12-lead ECG recording), urinalysis, and blood biochemical, haematological and serological examinations.

排除标准

•Women who are pregnant, nursing, unwilling to take adequate contraceptive precautions or undergo a urine pregnancy test
•Excess weekly alcohol consumption
•History of drug abuse
•Smoking > 10 cigarettes per day
•Unwilling to abstain from smoking throughout duration of the study
•Unable to abstain from prescription drugs within 14 days prior to the study, vitamins within 2 days prior to the study, grapefruit containing foods or beverages within 7 days prior to the study or caffeine containing foods or beverages within 24 hours prior to the study
•Used OTC herbal products within 3 days prior to the study
•Participating in another clinical trial within 80 days
•Clinically significant abnormal laboratory tests.

研究者

发起方

AFT Pharmaceuticals Ltd

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