An Open-label, Randomised, Three-way Cross-over, Single Dose, Single Centre, Comparative Pharmacokinetic Study Between Ibuprofen and Pseudoephedrine Liquid Capsules (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Test), Ibuprofen and Pseudoephedrine Tablets (2x 200 mg Ibuprofen & 30 mg Pseudoephedrine) (Comparator 1), and Ibuprofen Liquid Capsules (2x 200 mg Solubilised Ibuprofen) (Comparator 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Pseudoephedrine AUC0-t for Test vs. Comparator 1.
研究概览
简要总结
This comparative pharmacokinetic study is being conducted to provide supporting evidence for inclusion in dossiers to regulatory authorities for an Article 8(3) of Directive 2001/83/EC abridged application for ibuprofen and pseudoephedrine liquid capsules (200 mg ibuprofen & 30 mg pseudoephedrine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •Male or female subjects who have given written informed consent.
- •Age: ≥ 18 years ≤ 50 years.
- •Body Mass Index (BMI) of ≥ 20 and ≤ 30 kg/m
- •Healthy as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- •Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception unless of non-childbearing potential or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
- •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 or where abstaining from sexual intercourse in line with the preferred and usual lifestyle of the subject from first dose until 3 months after the final dose of study medication.
排除标准
- •Pregnant or lactating females.
- •A history and/or presence of significant disease of any body system, including psychiatric disorders.
- •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, other NSAIDs, pseudoephedrine, other sympathomimetic or catecholamine derivative decongestant drugs 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 hypertension or hypertension that is currently treated with antihypertensive medication.
- •A history of frequent dyspepsia, e.g. heartburn or indigestion.
- •A history of migraine.
- •Current smokers and ex-smokers who have smoked or used nicotine replacement products during the previous 6 months prior to first dosing.
- •A history of substance abuse (including alcohol).
- •High consumption of stimulating drinks (coffee, tea, cola, energy drinks etc.; total caffeine intake per day above 300 mg).
- •Those with positive screen/test for drugs of abuse and alcohol.
- •Those with a positive screen for ibuprofen.
- •Ingestion of a prescribed drug at any time in the 14 days before the first dose of study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers 30 days prior to the first dose of study medication.
- •Ingestion of an over-the-counter preparation within 7 days before the first dose of study medication, including herbal medications, vitamin/fish oil supplements, ibuprofen, other NSAIDs or decongestants.
- •Donation of blood in quantity > 400 ml e.g. to the blood transfusion service in the 12 weeks prior to the first dose of study medication
- •Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.
- •Topical use of ibuprofen within 7 days before the first dose of study medication.
- •Those previously randomised into this study.
- •Those who are an employee at the study site.
- •Those who are a partner or first degree relative of the Investigator.
- •Those who have participated in a clinical trial in the 12 weeks prior to the first dose of study medication.
- •Those unable in the opinion of the Investigator to comply fully with the study requirements.
- •Those who have consumed grapefruit or grapefruit juice, pummelo or Seville oranges in the 7 days prior to randomisation.
- •Those who are unwilling to consume gelatine of animal origin.
研究组 & 干预措施
4
Treatment Order: Comparator 1, Comparator 2, Test
干预措施: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules (Drug)
1
Treatment Order: Test, Comparator 1, Comparator 2
干预措施: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules (Drug)
1
Treatment Order: Test, Comparator 1, Comparator 2
干预措施: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets (Drug)
1
Treatment Order: Test, Comparator 1, Comparator 2
干预措施: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules (Drug)
2
Treatment Order: Test, Comparator 2, Comparator 1
干预措施: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules (Drug)
2
Treatment Order: Test, Comparator 2, Comparator 1
干预措施: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets (Drug)
4
Treatment Order: Comparator 1, Comparator 2, Test
干预措施: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets (Drug)
2
Treatment Order: Test, Comparator 2, Comparator 1
干预措施: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules (Drug)
3
Treatment Order: Comparator 1, Test, Comparator 2
干预措施: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules (Drug)
3
Treatment Order: Comparator 1, Test, Comparator 2
干预措施: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets (Drug)
3
Treatment Order: Comparator 1, Test, Comparator 2
干预措施: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules (Drug)
4
Treatment Order: Comparator 1, Comparator 2, Test
干预措施: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules (Drug)
5
Treatment Order: Comparator 2, Test, Comparator 1
干预措施: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules (Drug)
5
Treatment Order: Comparator 2, Test, Comparator 1
干预措施: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets (Drug)
5
Treatment Order: Comparator 2, Test, Comparator 1
干预措施: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules (Drug)
6
Treatment Order: Comparator 2, Comparator 1, Test
干预措施: Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules (Drug)
6
Treatment Order: Comparator 2, Comparator 1, Test
干预措施: Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets (Drug)
6
Treatment Order: Comparator 2, Comparator 1, Test
干预措施: Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules (Drug)
结局指标
主要结局
Pseudoephedrine AUC0-t for Test vs. Comparator 1.
时间窗: PK Analysis: 0-48hrs
The Test and Comparator 1 will be considered similar if for pseudoephedrine, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 1 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Pseudoephedrine Cmax for Test vs. Comparator 1.
时间窗: PK Analysis: 0-48hrs
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Ibuprofen AUC0-t for Test vs. Comparator 2.
时间窗: PK Analysis: 0-48hrs
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
Ibuprofen Cmax for Test vs. Comparator 2.
时间窗: PK Analysis: 0-48hrs
The Test and Comparator 2 will be considered similar if for ibuprofen, for each corresponding PK parameter, the 90% confidence interval for the Test to Comparator 2 ratio (rounded to two decimal places) of LS geometric means is fully contained within the interval 80.00 to 125.00%:
次要结局
- Ibuprofen AUC0-t for Test vs. Comparator 1.(PK Analysis: 0-48hrs)
- Ibuprofen Cmax for Test vs. Comparator 1.(PK Analysis: 0-48hrs)
- Assessment of how fast the ibuprofen from the Test product starts to be absorbed and how quickly it reaches the therapeutic level.(PK Analysis: 0-48hrs)
- Pharmacokinetic parameters will be assessed as secondary endpoints.(PK Analysis: 0-48hrs)