Bioequivalence Study of Two Commercial Amoxicillin Suspension Formulations in Healthy Human Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Changes in plasmatic amoxicillin concentrations along time measured by HPLC.
研究概览
简要总结
The aim of the present study was to compare the pharmacokinetic profiles and to evaluate the bioequivalence of two commercial amoxicillin-suspension formulations in healthy Brazilian volunteers.
详细描述
Under fasting condition, 25 volunteers (13 males and 12 females) were included in this randomized, open-label, two-period crossover (1-week washout interval) bioequivalence study. Blood samples were collected at pre-dose (0h) and 0.5, 1, 1.33, 1.66, 2, 2.5, 3, 4, 6, 8 and 12 hours after drug ingestion. Pharmacokinetic parameters (Cmax, Tmax, T1/2, Area-under-curve0-12h and Area-under-curve0-inf) were calculated from plasma concentrations for both formulations in each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •negative to HIV, hepatitis B virus, hepatitis C virus, addictive drugs and pregnancy test for women
- •age between 19 and 46 years
- •weight between 52 and 85 kg and body mass index between 17.6 and 28.4kg/m2
- •ability to provide written consent
- •laboratory exam results within the normal range for healthy individuals and/or medically acceptable defined by a clinical investigator;
- •feeding habits consistent with the standardization of the study
排除标准
- •pregnancy
- •history of hypersensitivity to penicillins (normal or idiosyncratic drug reaction)
- •any evidence of dysfunction or clinically significant deviation from normal
- •history of any psychiatric illness that might compromise the ability to provide written consent
- •history of gastrointestinal disease, hepatic, renal, pulmonary, cardiovascular, hematological, neurological or diabetes or glaucoma
- •active smoker
- •consumption of more than 5 cups of coffee or tea per day
- •history of drug dependence or abuse of alcohol consumption
- •use of enzymatic-inducers drugs within 30 days or any systemic medication (including prescription drugs, such as painkillers, hepatoprotective, influenza, etc) within 14 days before the start of the study
- •participation in any clinical study in 9 weeks prior to the study
- •have lost or donated more than 350 mL of blood in the last three months
- •have been subjected to abnormal diet for any reason (therapeutic, aesthetic, religious, etc.)
- •did not have adequate venous access.
研究组 & 干预措施
Amoxi-Ped
Single dose of 500 mg amoxicillin - AMOXI-PED - was administered after a 12-hour overnight fast.
干预措施: amoxicillin (Drug)
Amoxil
Single dose of 500 mg amoxicillin - AMOXIL - was administered after a 12-hour overnight fast.
干预措施: amoxicillin (Drug)
结局指标
主要结局
Changes in plasmatic amoxicillin concentrations along time measured by HPLC.
时间窗: Change from baseline to 12 hours
Amoxicillin were extracted from plasma by precipitating plasma proteins with acetonitrile. Amoxicillin plasmatic concentration was accessed every 30 minutes until 3h hours after drug administration and every 2h after this time until 12h of drug administration. Drug plasmatic concentrations were obtained by using a HPLC method.
次要结局
未报告次要终点
研究者
Francisco Groppo
Full Professor
University of Campinas, Brazil