NCT01350596已完成4 期
An Open Label, Randomized, 2x2 Crossover, Single Dose, Phase 4 Study To Determine The Pharmaceutical Bioequivalence Of Ibuprofen 50mg/Ml (Laboratórios Pfizer Ltda) Oral Suspension Versus Alivium ® 50mg/Ml (Mantecorp Indústria Química E Farmacêutica Ltda.) Oral Suspension, In Healthy Fasting Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug
研究概览
简要总结
An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral suspension versus alivium ® 50mg/ml (mantecorp indústria química e farmacêutica ltda.) Oral suspension, in healthy fasting volunteers.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy 18 to 55 years old male or female subjects (Healthy is defined as absence of clinically relevant abnormalities identified by detailed medical history, complete physical examination, including blood pressure and heart rate measurements, 12-lead ECG and clinical laboratory tests).
- •Volunteers' BMI - Body Mass Index must range from 18.5 to 24.9 (Dietary Guidelines for Americans), however, it can range to 15% of the upper limit (18.5 to 28.63) and total body weight >50kg.
- •Signed and dated Informed Consent Form by the subject or legally acceptable representative. If subject and/or legally acceptable representative is unable to read the Informed Consent Form, an impartial witness may sign it.
- •Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
排除标准
- •Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic clinically significant disease (including drug allergies, except for seasonal allergies, asymptomatic, untreated at the time of dosing).
- •Any condition that may possibly affect the drug absorption (e.g. gastrectomy).
- •Volunteer presenting a drug abuse history [patients making use of marijuana and hashish will be excluded if they used these drugs in less than three months before the medical appointment, and volunteers who have used drugs such as cocaine, phencyclidine (PCP), crack and heroin, will be excluded if they used them in less than one year before the medical appointment].
- •A positive drug test in urine (Methamphetamine, Opiate, Morphine, Marijuana, Cannabis, Amphetamine, Cocaine, Benzodiazepine, and Benzoylecgonine) or a positive test for alcohol before admission during periods 1 and
- •History of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 serving = 150 mL of wine or 360 mL of beer or 45 mL of concentrated liquor) within 6 months from selection.
- •If volunteer have participated in any experimental study or have taken any experimental drug within 6 months prior to baseline (ANVISA: RDC Resolution No. 34, June 3, 2008).
- •12-lead ECG demonstrating QTc> 450 msec at screening visit. If the QTc exceeds 450 msec, the ECG should be repeated twice and the average of the three QTc values should be used to determine patient's eligibility.
- •Pregnant or breastfeeding women, women of childbearing potential who are unwilling or unable to use a non-hormonal acceptable contraception method, as described in this protocol, from at least 14 days before the first dose of study medication.
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) before the first dose of study medication. Phytotherapic medicine and phytotherapic supplements should be discontinued 28 days before the first dose of study medication. With one exception, acetaminophen/paracetamol can be used at doses of 1 g/day. The limited use of nonprescription medications not considered as affecting the patient's safety or the general study results may be allowed on a case by case basis after sponsor's approval.
- •Blood donation of approximately 500 mL within 3 months before dosage.
- •Known hypersensitivity to Ibuprofen or chemically related compounds;
- •Volunteers in whom acetylsalicylic acid, iodate and other Nonsteroidal anti-inflammatory drugs have induced asthma, rhinitis, urticaria, nasal polyps, angioedema, bronchospasm and other symptoms of allergic or anaphylactic reactions.
- •Sensitivity History to heparin or heparin-induced thrombocytopenia.
- •Unwillingness or inability to comply with the Lifestyle Guidelines described in this protocol.
- •Other psychiatric or severe acute or clinically chronic condition or laboratory abnormality that may increase the risk associated with participation in the study or administration of investigational product, or which may interfere with the interpretation of study results and, in the opinion of the investigator, would make the patient inadequate to enter this study.
- •A positive beta HCG test in women.
- •If volunteer presents any condition that prevents his or her participation in the study, according to the opinion of the investigator.
- •Volunteer with gastroduodenal ulcer, or previous or active gastrointestinal bleeding.
研究组 & 干预措施
Reference Drug
Active Comparator
干预措施: Alivium® (Drug)
Test Drug
Active Comparator
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax) of Test Drug and Reference Drug
时间窗: Up to 16h
Area under the plasma concentration versus time curve from time zero to the last measurable concentration of Test Drug and Reference Drug (AUC(0-tlast))
时间窗: Up to 16h
次要结局
- Area under the plasma concentration versus time curve from time zero to infinity of Test Drug and Reference Drug (AUC(0-inf))(Up to 16h)
- Time to peak concentration of Test Drug and Reference Drug (Tmax)(Up to 16h)
- Half-life of Test Drug and Reference Drug (T1/2)(Up to 16h)
- Elimination rate constant (K el)(Up to 16h)
- Area under the curve from the time of dosing (AUC t/inf) extrapolated to infinity(Up to 16h)
研究者
研究点 (1)
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