NCT02503085已完成1 期
A Randomized, Single-dose, 4-way Crossover, Open-label, Pharmacokinetic (PK) Study Comparing a 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Nurofen for Children®) With a Swiss Reference 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Algifor Dolo Junior®) in the Fed and Fasted States
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have given written informed consent.
- •Age: ≥18 years ≤50 years.
- •Sex: Male or female subjects are eligible for entry.
- •Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception,
- •Female subject of non-child bearing potential with negative pregnancy test at the screening visit
- •Male subject willing to use an effective method of contraception, unless anatomically sterile
- •Status: Healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •Healthy Subjects with a Body Mass Index (BMI) of ≥20 and ≤27 kg/m2
排除标准
- •Pregnancy or lactating female subjects.
- •A history of significant disease of any body system.
- •Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
- •A history of allergy or intolerance related to treatment with ibuprofen, aspirin or other Non-Steroidal Anti-inflammatory Drug,or the excipients of the formulations.
- •A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
- •A history of frequent dyspepsia, e.g. heartburn or indigestion.
- •A history of migraine.
- •Current smokers and ex-smokers who have smoked within 6 months.
- •A history of drug abuse (including alcohol).
- •High consumption of stimulating drinks (caffeine intake per day above 300 mg).
- •Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
- •Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
- •Ingestion of an over-the-counter preparation within 7 days before dosing with study medication.
- •Donation of blood in quantity in the previous 12 weeks before enrolment into the study.
- •Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
- •Topical use of ibuprofen within 7 days before dosing with study medication.
- •Those previously randomised into this study.
- •Employee at study site.
- •Partner or first degree relative of the Investigator.
- •Those who have participated in a clinical trial in the previous 12 weeks.
- •Those unable in the opinion of the Investigator to comply fully with the study requirements.
研究组 & 干预措施
Nurofen for Children® (fasted)
Experimental
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition
干预措施: Nurofen for Children® (Drug)
Nurofen for Children® (fed)
Experimental
Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition
干预措施: Nurofen for Children® (Drug)
Algifor Dolo Junior® (fasted)
Active Comparator
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition
干预措施: Algifor Dolo Junior® (Drug)
Algifor Dolo Junior® (fed)
Active Comparator
Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition
干预措施: Algifor Dolo Junior® (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax)
时间窗: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)
时间窗: Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)
次要结局
- Elimination Rate Constant (Kel)(Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose))
- Time to Cmax (Tmax)(Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose))
- AUC From Administration to Infinity (AUC0-inf)(Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose))
- Plasma Concentration at Each Planned Nominal Time-point (Cn)(Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose))
- Number of Subjects With Adverse Events (AEs).(Up to follow-up day 7)
- Ratio of AUC0-t/AUC0-inf (AUCR)(Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose))
- Plasma Concentration Half-life (T1/2)(Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fasting ConditionsBioequivalencyNCT00804440Perrigo Company30
已完成
1 期
Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fed ConditionsBioequivalencyNCT00803946Perrigo Company30
已完成
1 期
Bioequivalence Study of Ibuprofen 200 mg Gel Capsules of Dr. Reddy's Laboratories Under Fasting ConditionHealthyNCT01149941Dr. Reddy's Laboratories Limited30
已完成
1 期
Bioequivalence Study of Ibuprofen 200 mg Soft Gel Capsules of Dr. Reddy's Laboratories Limited Under Fed ConditionsHealthyNCT01149954Dr. Reddy's Laboratories Limited30
已完成
1 期
A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult VolunteersHealthyNCT03697889McNeil AB28